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1.  Waist circumference is genetically correlated with incident Type 2 diabetes in Mexican-American families 
Aims
We aimed to determine the genetic and environmental correlation between various anthropometric indexes and incident Type 2 diabetes with a focus on waist circumference.
Methods
We used the data on extended Mexican-American families (808 subjects, 7617.92 person-years follow-up) from the San Antonio Family Heart Study and estimated the genetic and environmental correlations of 16 anthropometric indexes with the genetic liability of incident Type 2 diabetes. We performed bivariate trait analyses using the solar software package.
Results
All 16 anthropometric indexes were significantly heritable (range of heritabilities 0.24–0.99). Thirteen indexes were found to have significant environmental correlation with the liability of incident Type 2 diabetes. In contrast, only anthropometric indexes consisting of waist circumference (waist circumference, waist–hip ratio and waist–height ratio) were significantly genetically correlated (genetic correlation coefficients: 0.45, 0.55 and 0.44, respectively) with the liability of incident Type 2 diabetes. We did not observe such a correlation for BMI.
Conclusions
Waist circumference as a predictor of future Type 2 diabetes is supported by shared genetic influences.
doi:10.1111/dme.12266
PMCID: PMC3849209  PMID: 23796311
2.  Racial/ethnic differences in hepatic steatosis in a population-based cohort of post-menopausal women: the Michigan Study of Women’s Health Across the Nation 
Aims
The prevalence of hepatic steatosis may differ between post-menopausal African-Americans and non-Hispanic white women and by sex hormone binding globulin level. We examined prevalence of hepatic steatosis by race/ethnicity and associations with sex hormone binding globulin.
Methods
Participants included post-menopausal women who underwent hepatic ultrasound (n = 345) at the Michigan site of the Study of Women’s Health Across the Nation, a population-based study. We examined hepatic steatosis prevalence by race/ethnicity and used logistic regression models to calculate the odds of hepatic steatosis with race/ethnicity and sex hormone binding globulin, after adjustment for age, alcohol use, waist circumference, HDL cholesterol, triglycerides, systolic blood pressure and use of medications reported to lower intrahepatic fat.
Results
Fewer African-Americans than non-Hispanic white women had hepatic steatosis (23 vs. 36%, P = 0.01). African-Americans had lower triglyceride and LDL cholesterol levels, but higher blood pressure and follicle-stimulating hormone levels (P < 0.05). In the optimal-fitting multivariable models, women in the highest tertile of sex hormone binding globulin (60.2–220.3 nmol/l) had a lower odds of hepatic steatosis (odds ratio 0.43, 95% CI 0.20–0.93) compared with women in the lowest tertile of sex hormone binding globulin (10.5–40.3 nmol/l). There was an interaction between race/ethnicity and medication use whereby non-Hispanic white women using medications had three times higher odds of hepatic steatosis compared with African-Americans not using medications (odds ratio 3.36, 95% CI 1.07–10.58). Interactions between race/ethnicity and other variables, including sex hormone levels, were not significant.
Conclusions
Hepatic steatosis on ultrasound may be more common in post-menopausal non-Hispanic white women than African-Americans and was associated with lower levels of sex hormone binding globulin.
doi:10.1111/dme.12225
PMCID: PMC3786038  PMID: 23659546
3.  Short Report: Complications Delay in diabetic retinopathy screening increases the rate of detection of referable diabetic retinopathy 
Diabetic Medicine  2013;31(1):439-442.
Aims
To assess whether there is a relationship between delay in retinopathy screening after diagnosis of Type 2 diabetes and level of retinopathy detected.
Methods
Patients were referred from 88 primary care practices to an English National Health Service diabetic eye screening programme. Data for screened patients were extracted from the primary care databases using semi-automated data collection algorithms supplemented by validation processes. The programme uses two-field mydriatic digital photographs graded by a quality assured team.
Results
Data were available for 8183 screened patients with diabetes newly diagnosed in 2005, 2006 or 2007. Only 163 with Type 1 diabetes were identified and were insufficient for analysis. Data were available for 8020 with newly diagnosed Type 2 diabetes. Of these, 3569 were screened within 6 months, 2361 between 6 and 11 months, 1058 between 12 and 17 months, 366 between 18 and 23 months, 428 between 24 and 35 months, and 238 at 3 years or more after diagnosis. There were 5416 (67.5%) graded with no retinopathy, 1629 (20.3%) with background retinopathy in one eye, 753 (9.4%) with background retinopathy in both eyes and 222 (2.8%) had referable diabetic retinopathy. There was a significant trend (P = 0.0004) relating time from diagnosis to screening detecting worsening retinopathy. Of those screened within 6 months of diagnosis, 2.3% had referable retinopathy and, 3 years or more after diagnosis, 4.2% had referable retinopathy.
Conclusions
The rate of detection of referable diabetic retinopathy is elevated in those who were not screened promptly after diagnosis of Type 2 diabetes.
doi:10.1111/dme.12313
PMCID: PMC4232880  PMID: 24093530
4.  Research: Care Delivery Development and validation of the Diabetes Medication System Rating Questionnaire-Short Form 
Diabetic Medicine  2014;31(10):1237-1244.
Aims
To develop and validate a short form of the 54-item Diabetes Medication System Rating Questionnaire that maintains the domains and performance characteristics of the long-form questionnaire.
Methods
Data from the Diabetes Medication System Rating Questionnaire validation study were analysed to select items representing the nine scales (convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference). The resulting 20-item Diabetes Medication System Rating Questionnaire Short-Form was administered online, with validated criterion measures of treatment satisfaction and medication adherence, with a retest within 2 weeks. Participants were US adults (N = 413) with Type 2 diabetes using oral agents alone; insulin by syringe and/or pen with or without oral agents; or glucagon-like peptide-1 agents. Most participants (82%) completed the retest.
Results
The median inter-item agreement of scales was 0.76 and the total composite (mean of all items except treatment preference) was 0.88. The median test-retest reliability of scales was 0.86, and of the total composite was 0.95. All statistically significant correlations between Diabetes Medication System Rating Questionnaire Short-Form scales and criterion measures of treatment satisfaction and adherence were in the expected direction. The median correlation of the Diabetes Medication System Rating Questionnaire Short-Form with corresponding criterion measures of treatment satisfaction was 0.59; the mean correlation of the same Diabetes Medication System Rating Questionnaire Short-Form measures with adherence was 0.42. The Diabetes Medication System Rating Questionnaire Short-Form scales were more powerful predictors of adherence than were the criterion measures of treatment satisfaction. The Diabetes Medication System Rating Questionnaire Short-Form scales differentiated between those taking different medications and between those using different insulin delivery devices.
Conclusions
This study suggests that the Diabetes Medication System Rating Questionnaire Short-Form provides a comprehensive set of measures with acceptable reliability and validity and a reduced burden of administration.
What’s new?
This study reports the development and validation of a short form of the Diabetes Medication System Rating Questionnaire (DMSRQ) that maintains the domains and performance of the long-form questionnaire.
Like the Diabetes Medication System Rating Questionnaire, the Diabetes Medication System Rating Questionnaire-Short Form (DMSRQ-SF) has good reliability and enhanced validity relative to other comparable measures.
The DMSRQ-SF has a lower burden of administration than the DMSRQ, which makes it suitable for use in clinical settings as well as research.
Each of the DMSRQ-SF therapy perception items was chosen to have unique validity and applicability as a single-item measure, i.e. to assess an independent aspect of treatment satisfaction that discriminates treatments and drives global assessments of treatments.
doi:10.1111/dme.12453
PMCID: PMC4232890  PMID: 24673614
5.  Research: Adolescents with Type 1 diabetes mellitus experience psychosensorial symptoms during hypoglycaemia 
Diabetic Medicine  2014;31(1):1245-1251.
Aim
To describe mood and psychosensorial symptoms of hypoglycaemia in adolescents with Type 1 diabetes mellitus in two countries with different cultures, Turkey and the USA.
Methods
We developed a 68-item questionnaire assessing physical, behavioural, mood and psychosensorial symptom frequency and ratings [‘good’, ‘bad’, or ‘both’ (sometimes good, sometimes bad)]. Adolescents with Type 1 diabetes were recruited from paediatric diabetes clinics at the University of North Carolina at Chapel Hill in the USA and Kocaeli University in Turkey. The percentages of participants at each clinic who endorsed individual symptoms, symptom categories and symptom ratings were calculated and compared.
Results
Cronbach’s α values were > 0.7 for each real symptom category. No symptom items were excluded from the questionnaire analysis based on item-total correlation results which were all > 0.2. Data were collected from 132 participants (69 from University of North Carolina, 63 from Kocaeli University, 54% male). The mean (sd) age of the participants was 14.9 (1.9) years, HbA1c level was 8.7 (1.8) % and duration of Type 1 diabetes was 5.8 (3.7) years. On average, each physical symptom was experienced by 65.2% of participants, each behavioural symptom by 46.5%, each mood symptom by 42.8%, and each psychosensorial symptom by 48.9%. On average, each physical, behavioral, mood and psychosensorial symptom was rated as ‘good’ or ‘both’ by 23.0, 29.1, 36.9 and 37.2% of participants, respectively. There were no symptom differences between the groups in each country.
Conclusions
In addition to the classic physical symptoms experienced during hypoglycaemia, adolescents with Type 1 diabetes report psychosensorial, mood and behavioral symptoms, and some describe them as positive experiences. Symptom experiences were similar in these two countries with different cultures.
doi:10.1111/dme.12533
PMCID: PMC4167966  PMID: 24965522
6.  Research: Complications Self-reported non-severe hypoglycaemic events in Europe 
Diabetic Medicine  2013;31(1):92-101.
Aims
Hypoglycaemia presents a barrier to optimum diabetes management but data are limited on the frequency of hypoglycaemia incidents outside of clinical trials. The present study investigated the rates of self-reported non-severe hypoglycaemic events, hypoglycaemia awareness and physician discussion of events in people with Type 1 diabetes mellitus or insulin-treated Type 2 diabetes mellitus.
Methods
People in seven European countries aged >15 years with Type 1 diabetes or insulin–treated Type 2 diabetes (basal-only, basal-bolus and other insulin regimens) were recruited via consumer panels, nurses, telephone recruitment and family referrals. Respondents completed four online questionnaires. The first questionnaire collected background information on demographics and hypoglycaemia-related behaviour, whilst all four questionnaires collected data on non-severe hypoglycaemic events in the preceding 7 days.
Results
Analysis was based on 11 440 respondent-weeks from 3827 respondents. All participants completed the first questionnaire and 57% completed all four. The mean number of events/respondent–week was 1.8 (Type 1 diabetes) and 0.4–0.7 (Type 2 diabetes, with different insulin treatments) corresponding to annual event rates of 94 and 21–36, respectively. A total of 63% of respondents with Type 1 diabetes and 49–64% of respondents with Type 2 diabetes, treated with different insulin regimens, who experienced hypoglycaemic events, reported impaired hypoglycaemia awareness or unawareness. A high proportion of respondents rarely or never informed their general practitioner/specialist about hypoglycaemia: 65% (Type 1 diabetes) and 50–59% (Type 2 diabetes). Overall, 16% of respondents with Type 1 diabetes and 26% of respondents with Type 2 diabetes reported not being asked about hypoglycaemia during routine appointments.
Conclusion
Non-severe hypoglycaemic events are common amongst people with Type 1 diabetes and insulin–treated Type 2 diabetes in real-world settings. Many rarely or never inform their general practitioner/specialist about their hypoglycaemia and the real burden of hypoglycaemia may be underestimated.
doi:10.1111/dme.12261
PMCID: PMC4232857  PMID: 23796113
7.  Research: Educational and Psychological Issues Effectiveness of a group diabetes education programme in under-served communities in South Africa: a pragmatic cluster randomized controlled trial 
Diabetic Medicine  2014;31(8):987-993.
Aim
To evaluate the effectiveness of group education, led by health promoters using a guiding style, for people with Type 2 diabetes in public sector community health centres in Cape Town.
Methods
This was a pragmatic clustered randomized controlled trial with 17 randomly selected intervention and 17 control sites. A total of 860 patients with Type 2 diabetes, regardless of therapy used, were recruited from the control sites and 710 were recruited from the intervention sites. The control sites offered usual care, while the intervention sites offered a total of four monthly sessions of group diabetes education led by a health promoter. Participants were measured at baseline and 12 months later. Primary outcomes were diabetes self-care activities, 5% weight loss and a 1% reduction in HbA1c levels. Secondary outcomes were self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c and mean total cholesterol levels and quality of life.
Results
A total of 422 (59.4%) participants in the intervention group did not attend any education sessions. No significant improvement was found in any of the primary or secondary outcomes, apart from a significant reduction in mean systolic (-4.65 mmHg, 95% CI 9.18 to -0.12; P = 0.04) and diastolic blood pressure (-3.30 mmHg, 95% CI -5.35 to -1.26; P = 0.002). Process evaluation suggested that there were problems with finding suitable space for group education in these under-resourced settings, with patient attendance and with full adoption of a guiding style by the health promoters.
Conclusion
The reported effectiveness of group diabetes education offered by more highly trained professionals, in well-resourced settings, was not replicated in the present study, although the reduction in participants’ mean blood pressure is likely to be of clinical significance.
What’s new?
The study adds to the scarce literature on diabetes education in Africa in the face of a growing public health problem in this continent.
The study demonstrates a statistically and clinically significant reduction in participants’ mean blood pressure 1 year after the educational intervention.
The study adds to the small amount of literature on group motivational interviewing type interventions for diabetes.
The study adds to the small amount of literature on the use of lower-/mid-level health workers for diabetes education.
doi:10.1111/dme.12475
PMCID: PMC4232864  PMID: 24766179
8.  Research: Treatment Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial 
Diabetic Medicine  2014;31(9):1069-1077.
Aims
Among people with diabetes, 10–25% will experience a foot ulcer. Research has shown that supplementation with arginine, glutamine and β-hydroxy-β-methylbutyrate may improve wound repair. This study tested whether such supplementation would improve healing of foot ulcers in persons with diabetes.
Methods
Along with standard of care, 270 subjects received, in a double-blinded fashion, (twice per day) either arginine, glutamine and β-hydroxy-β-methylbutyrate or a control drink for 16 weeks. The proportion of subjects with total wound closure and time to complete healing was assessed. In a post-hoc analysis, the interaction of serum albumin or limb perfusion, as measured by ankle–brachial index, and supplementation on healing was investigated.
Results
Overall, there were no group differences in wound closure or time to wound healing at week 16. However, in subjects with an albumin level of ≤ 40 g/l and/or an ankle–brachial index of < 1.0, a significantly greater proportion of subjects in the arginine, glutamine and β-hydroxy-β-methylbutyrate group healed at week 16 compared with control subjects (P = 0.03 and 0.008, respectively). Those with low albumin or decreased limb perfusion in the supplementation group were 1.70 (95% CI 1.04–2.79) and 1.66 (95% CI 1.15–2.38) times more likely to heal.
Conclusions
While no differences in healing were identified with supplementation in non-ischaemic patients or those with normal albumin, addition of arginine, glutamine and β-hydroxy-β-methylbutyrate as an adjunct to standard of care may improve healing of diabetic foot ulcers in patients with risk of poor limb perfusion and/or low albumin levels. Further investigation involving arginine, glutamine and β-hydroxy-β-methylbutyrate in these high-risk subgroups might prove clinically valuable.
doi:10.1111/dme.12509
PMCID: PMC4232867  PMID: 24867069
9.  Research: Treatment Study to determine the durability of glycaemic control with early treatment with a vildagliptin–metformin combination regimen vs. standard-of-care metformin monotherapy—the VERIFY trial: a randomized double-blind trial 
Diabetic Medicine  2014;31(1):1178-1184.
Aims
Durability of good glycaemic control (HbA1c) is of importance as it can be the foundation for delaying diabetic complications. It has been hypothesized that early initiation of treatment with the combination of oral anti-diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents. Dipeptidyl peptidase-4 inhibitors are good candidates for early use as they are efficacious in combination with metformin, show weight neutrality and a low risk of hypoglycaemia. We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows β-cell deterioration as measured by HbA1c.
Methods
Approximately 2000 people with Type 2 diabetes mellitus who were drug-naive or who were treated with metformin for less than 1 month, and who have HbA1c of 48–58 mmol/mol (6.5–7.5%), will be randomized in a 1:1 ratio in VERIFY, a 5-year multinational, double-blind, parallel-group study designed to compare early initiation of a vildagliptin–metformin combination with standard-of-care initiation of metformin monotherapy, followed by the stepwise addition of vildagliptin when glycaemia deteriorates. Further deterioration will be treated with insulin. The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co-primary endpoints.
Summary
VERIFY is the first study to investigate the long-term clinical benefits of early combination treatment vs. the standard-of-care metformin monotherapy with a second agent added by threshold criteria.
doi:10.1111/dme.12508
PMCID: PMC4232870  PMID: 24863949
10.  Research: Treatment Factors associated with statin treatment for the primary prevention of cardiovascular disease in people within 2 years following diagnosis of diabetes in Scotland, 2006–2008 
Diabetic Medicine  2014;31(1):640-646.
Aim
To describe characteristics associated with statin prescribing for the primary prevention of cardiovascular disease in people with newly diagnosed diabetes.
Methods
Data from the Scottish Care Information—Diabetes Collaboration data set for 2006–2008 were used. This data set contains socio-demographic and prescribing data for over 99% of people with diagnosed diabetes in Scotland. Analyses were conducted on people aged over 40 years diagnosed with Type 1 or Type 2 diabetes between 2006 and 2008 with complete data and no previous history of cardiovascular or statin prescription. Logistic regression was used to calculate odds ratios for statin prescription in the 2 years following diagnosis of diabetes.
Results
There were 7157 men and 5601 women who met the inclusion criteria, 68% of whom had a statin prescription recorded in the 2 years following diagnosis of diabetes. The proportions receiving statins were lower above 65 years of age in men and 75 years of age in women. People with Type 1 diabetes had lower odds of receiving statins than people with Type 2 diabetes [odds ratio (95% CI) 0.42 (0.29–0.61) for men and 0.48 (0.28–0.81) for women, after adjustment for age, BMI, smoking status, cholesterol level and deprivation]. Higher total cholesterol, BMI and being a current smoker were associated with greater odds of statin prescription.
Conclusion
Approximately one third of the study population had no record of statin prescription during the 2 years after diagnosis of diabetes. Cardiovascular disease risk reduction opportunities may be missed in some of these people.
doi:10.1111/dme.12409
PMCID: PMC4232871  PMID: 24533646
11.  Physical activity interventions in children and young people with Type 1 diabetes mellitus: a systematic review with meta-analysis 
Diabetic Medicine  2014;31(1):1163-1173.
Aims
To synthesize evidence from randomized and non-randomized studies of physical activity interventions in children and young people with Type 1 diabetes so as to explore clinically relevant health outcomes and inform the promotion of physical activity.
Method
We conducted a search of CINAHL Plus, the Cochrane Library, EMBASE, MEDLINE, PsycINFO, SCOPUS, SportDiscus and Web of Science between October and December 2012. Eligible articles included subjects aged ≤18 years with Type 1 diabetes and a physical activity intervention that was more than a one-off activity session. Physiological, psychological, behavioural or social outcomes were those of interest.
Results
A total of 26 articles (10 randomized and 16 non-randomized studies), published in the period 1964–2012, were reviewed. Although there was heterogeneity in study design, methods and reporting, 23 articles reported at least one significant beneficial health outcome at follow-up. Meta-analyses of these studies showed potential benefits of physical activity on HbA1c (11 studies, 345 participants, standardized mean difference -0.52, 95% CI -0.97 to -0.07; P = 0.02), BMI (four studies, 195 participants, standardized mean difference -0.41, 95% CI -0.70 to -0.12; P = 0.006) and triglycerides (five studies, 206 participants, standardized mean difference -0.70, 95% CI -1.25 to -0.14; P = 0.01).The largest effect size was for total cholesterol (five studies, 206 participants, standardized mean difference -0.91, 95% CI -1.66 to -0.17; P = 0.02).
Conclusions
Physical activity is important for diabetes management and has the potential to delay cardiovascular disease, but there is a lack of studies that are underpinned by psychological behaviour change theory, promoting sustained physical activity and exploring psychological outcomes. There remains a lack of knowledge of how to promote physical activity in people with Type 1 diabetes.
doi:10.1111/dme.12531
PMCID: PMC4232875  PMID: 24965376
12.  Hepcidin levels in diabetes mellitus and polycystic ovary syndrome 
Diabetic Medicine  2013;30(12):1495-1499.
Aim
Increased body iron is associated with insulin resistance. Hepcidin is the key hormone that negatively regulates iron homeostasis. We hypothesized that individuals with insulin resistance have inadequate hepcidin levels for their iron load.
Methods
Serum concentrations of the active form of hepcidin (hepcidin-25) and hepcidin:ferritin ratio were evaluated in participants with Type 2 diabetes (n = 33, control subjects matched for age, gender and BMI,n = 33) and participants with polycystic ovary syndrome (n = 27, control subjects matched for age and BMI,n = 16). To investigate whether any changes observed were associated with insulin resistance rather than insulin deficiency or hyperglycaemia per se, the same measurements were made in participants with Type 1 diabetes (n = 28, control subjects matched for age, gender and BMI,n = 30). Finally, the relationship between homeostasis model assessment of insulin resistance and serum hepcidin:ferritin ratio was explored in overweight or obese participants without diabetes (n = 16).
Results
Participants with Type 2 diabetes had significantly lower hepcidin and hepcidin:ferritin ratio than control subjects (P < 0.05 and P < 0.01, respectively). Participants with polycystic ovary syndrome had a significantly lower hepcidin:ferritin ratio than control subjects (P < 0.05). There was no significant difference in hepcidin or hepcidin:ferritin ratio between participants with Type 1 diabetes and control subjects (P = 0.88 and P = 0.94). Serum hepcidin:ferritin ratio inversely correlated with homeostasis model assessment of insulin resistance (r = –0.59, P < 0.05).
Conclusion
Insulin resistance, but not insulin deficiency or hyperglycaemia per se, is associated with inadequate hepcidin levels. Reduced hepcidin concentrations may cause increased body iron stores in insulin-resistant states.
doi:10.1111/dme.12262
PMCID: PMC4232927  PMID: 23796160
13.  Role of the kidney in normal glucose homeostasis and in the hyperglycaemia of diabetes mellitus: therapeutic implications 
Diabetic Medicine  2010;27(2):136-142.
Abstract
Considerable data have accumulated over the past 20 years, indicating that the human kidney is involved in the regulation of glucose via gluconeogenesis, taking up glucose from the circulation, and by reabsorbing glucose from the glomerular filtrate. In light of the development of glucose-lowering drugs involving inhibition of renal glucose reabsorption, this review summarizes these data. Medline was searched from 1989 to present using the terms ‘renal gluconeogenesis’, ‘renal glucose utilization’, ‘diabetes mellitus’ and ‘glucose transporters’. The human liver and kidneys release approximately equal amounts of glucose via gluconeogenesis in the post-absorptive state. In the postprandial state, although overall endogenous glucose release decreases substantially, renal gluconeogenesis increases by approximately twofold. Glucose utilization by the kidneys after an overnight fast accounts for ∼10% of glucose utilized by the body. Following a meal, glucose utilization by the kidney increases. Normally each day, ∼180 g of glucose is filtered by the kidneys; almost all of this is reabsorbed by means of sodium–glucose co-transporter 2 (SGLT2), expressed in the proximal tubules. However, the capacity of SGLT2 to reabsorb glucose from the renal tubules is finite and, when plasma glucose concentrations exceed a threshold, glucose appears in the urine. Handling of glucose by the kidney is altered in Type 2 diabetes mellitus (T2DM): renal gluconeogenesis and renal glucose uptake are increased in both the post-absorptive and postprandial states, and renal glucose reabsorption is increased. Specific SGLT2 inhibitors are being developed as a novel means of controlling hyperglycaemia in T2DM.
Diabet. Med. 27, 136–142 (2010)
doi:10.1111/j.1464-5491.2009.02894.x
PMCID: PMC4232006  PMID: 20546255
gluconeogenesis; kidney; sodium glucose co-transporter 2; Type 2 diabetes mellitus
14.  Research: Treatment A randomized crossover study to assess the effect of an oat-rich diet on glycaemic control, plasma lipids and postprandial glycaemia, inflammation and oxidative stress in Type 2 diabetes 
Diabetic Medicine  2013;30(11):1314-1323.
Aims
In the UK, lifestyle intervention is first-line management in Type 2 diabetes. It is unclear what type of diet is most efficacious for improving glycaemic control. This study investigated the effects of an oat-enriched diet on glycaemic control, postprandial glycaemia, inflammation and oxidative stress compared with standard dietary advice.
Methods
In a randomized crossover design, 27 volunteers with Type 2 diabetes, managed on diet and lifestyle only, were observed for two consecutive 8-week periods following either the oat-enriched diet or re-enforced standard dietary advice. Volunteers attended at baseline (habitual intake) and 8 and 16 weeks. Measurements included basic clinical measurements and fasted and postprandial (3-h) glucose and insulin in response to a healthy test meal. Markers of inflammation and oxidative stress, including high-sensitivity C-reactive protein, interleukin 6, interleukin 18, tumour necrosis factor-alpha, adiponectin, thiobarbituric acid reactive substances, oxygen radical antioxidant capacity, oxidized LDL and urinary isoprostanes, were also measured at fasting and in the postprandial period.
Results
There were no diet-related effects on glycaemic control or glycaemic or insulinaemic responses to the test meal. Total cholesterol (5.1 ± 1.0 vs. 4.9 ± 0.8 mmol/l, P = 0.019) concentrations declined following the oat-enriched diet compared with standard dietary advice. There was a postprandial decline in adiponectin concentration (P = 0.009), but no effect of dietary intervention. None of the measures of oxidative stress or inflammation were altered by the oat-enriched diet compared with standard dietary advice.
Conclusion
The oat-enriched diet had a modest impact on lipid lowering, but did not impact on oxidative stress or inflammation in these volunteers with Type 2 diabetes.
doi:10.1111/dme.12228
PMCID: PMC4232050  PMID: 23668675
15.  Vitamin D in youth with Type 1 diabetes: prevalence of insufficiency and association with insulin resistance in the SEARCH Nutrition Ancillary Study 
Aims
To determine the prevalence of plasma vitamin D insufficiency in individuals with Type 1 diabetes and to determine the cross-sectional and longitudinal associations of plasma vitamin D with insulin resistance.
Methods
Participants from the SEARCH for Diabetes in Youth Study [n = 1426; mean age 11.2 years (sd 3.9)] had physician-diagnosed Type 1 diabetes [diabetes duration mean 10.2 months (sd 6.5)] with data available at baseline and follow-up (approximately 12 and 24 months after baseline). Insulin resistance was estimated using a validated equation. Cross-sectional and longitudinal multivariate logistic regression models were used to determine the association of plasma vitamin D with insulin resistance, adjusting for potential confounders.
Results
Forty-nine per cent of individuals had plasma vitamin D < 50 nmol/l and 26% were insulin resistant. In cross-sectional multivariate analyses, participants who had higher plasma vitamin D (65 nmol/l) had lower odds of prevalent insulin resistance than participants with lower plasma vitamin D (25 nmol/l) (odds ratio 0.70, 95% CI 0.57–0.85). This association was attenuated after additional adjustment for BMI z-score, which could be a confounder or a mediator (odds ratio 0.81, 95% CI 0.64–1.03). In longitudinal multivariate analyses, individuals with higher plasma vitamin D at baseline had lower odds of incident insulin resistance, but this was not significant (odds ratio 0.85, 95% CI 0.63–1.14).
Conclusions
Vitamin D insufficiency is common in individuals with Type 1 diabetes and may increase risk for insulin resistance. Additional prospective studies are needed to determine the association between plasma vitamin D and insulin resistance, and to further examine the role of adiposity on this association.
doi:10.1111/dme.12297
PMCID: PMC3822440  PMID: 23909945
16.  Assessment of the under-reporting of diabetes in hospital admission data: a study from the Scottish Diabetes Research Network Epidemiology Group 
Summary
Aims
Good quality data are required to plan and evaluate diabetes services and to assess progress against targets for reducing hospital admissions and bed days. The aim of this study was to assess the completeness of recording of diabetes in hospital admissions using recent national data for Scotland.
Methods
Data derived from linkage of the Scottish national diabetes register and hospital admissions data were analysed to assess the completeness of coding of diabetes in hospital inpatient admissions between 2000 and 2007 for patients identified with diabetes prior to hospital admission.
Results
In 2007 only 59% of hospital inpatient admissions for people previously diagnosed with diabetes mentioned diabetes, whereas over 99% of people with a mention of diabetes on hospital records were included in the diabetes register. The completeness of diabetes recording varied from 44% to 82% among mainland NHS Boards and from 34% to 89% among large general hospitals. Completeness of recording of diabetes as a co-morbidity also varied by primary diagnosis: 70% and 41% of admissions with coronary heart disease and cancer as the primary diagnosis mentioned co-existing diabetes respectively.
Conclusion
There is wide variation in the completeness of recording of diabetes in hospital admission data. Hospital data alone considerably underestimate the number of admissions and bed days but overestimate length of stay for people with diabetes. Linkage of diabetes register data to hospital admissions data provides a more accurate source for measuring hospital admissions among people diagnosed with diabetes than hospital admissions data.
doi:10.1111/j.1464-5491.2011.03432.x
PMCID: PMC4215191  PMID: 21883441
Diabetes; Hospital admissions; Linkage
17.  Apolipoprotein M can discriminate HNF1A-MODY from Type 1 diabetes 
Aims
Missed diagnosis of maturity-onset diabetes of the young (MODY) has led to an interest in biomarkers that enable efficient prioritization of patients for definitive molecular testing. Apolipoprotein M (apoM) was suggested as a biomarker for hepatocyte nuclear factor 1 alpha (HNF1A)-MODY because of its reduced expression in Hnf1a−/− mice. However, subsequent human studies examining apoM as a biomarker have yielded conflicting results. We aimed to evaluate apoM as a biomarker for HNF1A-MODY using a highly specific and sensitive ELISA.
Methods
ApoM concentration was measured in subjects with HNF1A-MODY (n = 69), Type 1 diabetes (n = 50), Type 2 diabetes (n = 120) and healthy control subjects (n = 100). The discriminative accuracy of apoM and of the apoM/HDL ratio for diabetes aetiology was evaluated.
Results
Mean (standard deviation) serum apoM concentration (μmol/l) was significantly lower for subjects with HNF1A-MODY [0.86 (0.29)], than for those with Type 1 diabetes [1.37 (0.26), P = 3.1 × 10−18) and control subjects [1.34 (0.22), P = 7.2 × 10−19). There was no significant difference in apoM concentration between subjects with HNF1A-MODY and Type 2 diabetes [0.89 (0.28), P = 0.13]. The C-statistic measure of discriminative accuracy for apoM was 0.91 for HNF1A-MODY vs. Type 1 diabetes, indicating high discriminative accuracy. The apoM/HDL ratio was significantly lower in HNF1A-MODY than other study groups. However, this ratio did not perform well in discriminating HNF1A-MODY from either Type 1 diabetes (C-statistic = 0.79) or Type 2 diabetes (C-statistic = 0.68).
Conclusions
We confirm an earlier report that serum apoM levels are lower in HNF1A-MODY than in controls. Serum apoM provides good discrimination between HNF1A-MODY and Type 1 diabetes and warrants further investigation for clinical utility in diabetes diagnostics.
doi:10.1111/dme.12066
PMCID: PMC4193536  PMID: 23157689
18.  Racial Disparities in the Control Status of Cardiovascular Risk Factors in an Underinsured Population with Type 2 Diabetes 
Aims
To investigate the race-specific trend in attainment of the American Diabetes Association (ADA) cardiovascular risk factors control goals of patients with type 2 diabetes (HbA1c <53 mmol/mol [7.0%], blood pressure <130/80 mmHg, and low-density lipoprotein [LDL] cholesterol <2.6 mmol/L).
Methods
The study sample included 14,946 African American and 12,758 White patients who were newly diagnosed with type 2 diabetes between 2001 and 2009 in the Louisiana State University Hospital System. The race-specific percentages of patients’ attainment of ADA goals were calculated using the baseline and follow-up measurements of HbA1c, blood pressure, and LDL-cholesterol levels. Logistic regression was used to test the difference between African American and White patients.
Results
The percentage of patients who met all three ADA goals increased from 8.2% in 2001 to 10.2% in 2009 (increased by 24.4%) in this cohort. Compared with African American patients, White patients had better attainment of the following ADA goals: HbA1c goal (61.4 vs. 55.1%), blood pressure goal (25.8 vs. 20.4%), LDL-cholesterol goal (40.1 vs. 37.7%), and all three goals (7.3 vs. 5.1%). African American and White patients generally had improved CVD risk factors profile during follow-up when we assessed attainment of the ADA goals by using means of HbA1c, blood pressure and LDL cholesterol.
Conclusions
During 2001–2009, this low income cohort with type 2 diabetes generally experienced improved control of CVD risk factors. White patients had better attainment of the ADA cardiovascular risk factors control goals than their African American counterparts.
doi:10.1111/dme.12470
PMCID: PMC4167915  PMID: 24750373
19.  Trying to understand gestational diabetes 
Women with normal glucose tolerance pre-gravid and developing gestational diabetes in late gestation have subclinical metabolic dysfunction prior to conception compared with women with normal glucose tolerance. Because of the 60 % decrease in insulin sensitivity with normal pregnancy, these women develop clinical hyperglycaemia/gestational diabetes in late gestation. The metabolic dysfunction includes impaired insulin response, decreased hepatic suppression of glucose production during insulin infusion and decreased insulin-stimulated glucose uptake in skeletal muscle, i.e. peripheral insulin resistance. The insulin resistance in normal glucose tolerance pregnancy is related to a decrease in the post-receptor insulin signalling cascade, specifically decreased insulin receptor substrate 1 tyrosine phosphorylation. In women with normal glucose tolerance this is reversed post-partum. In contrast, in gestational diabetes, in addition to the decrease in insulin receptor substrate 1 tyrosine phosphorylation, there is an additional decrease in tyrosine phosphorylation of the intracellular portion of the insulin receptor that is not related to the insulin receptor protein content. Post-partum women with gestational diabetes, who had retention of gestational weight gain, had no significant improvement in insulin sensitivity and increased inflammation expressed as increased plasma and skeletal muscle tumour necrosis factor alpha. The increased inflammation or meta-inflammation is a hallmark of obesity and during pregnancy develops in both white adipose tissue and placenta. Last gene array studies of placenta were associated with alterations in gene expression relating primarily to lipid in contrast to glucose metabolic pathways in gestational diabetes compared with Type 1 diabetes. Future studies are directed at decreasing inflammation prior to and during pregnancy using various lifestyle and nutritional interventions.
doi:10.1111/dme.12381
PMCID: PMC4178541  PMID: 24341419
20.  Disclosure of psychosocial stressors affecting diabetes care among uninsured young adults with Type 1 diabetes 
Aims
To determine the disclosure rates of psychosocial issues affecting routine diabetes care.
Methods
A total of 20 young adults were interviewed regarding the impact of psychosocial stressors on their diabetes care. The interviewer, endocrinologist and case manager reported the prevalence rates of psychosocial stressors. Disclosure rates were compared to determine the prevalence of psychosocial issues and the different patterns of disclosure.
Results
Participants reported a high number of psychosocial stressors, which were associated with poorer glycaemic control (r = 0.60, P = 0.005). Approximately half of all disclosed stressors (50.9%) were identified in routine care; other stressors were identified only through intensive case management and/or in-depth interviews.
Conclusions
Identifying psychosocial stressors in routine care, and providing referrals to psychological or social services, is a significant unmet need and may improve glycaemic control among certain populations with diabetes. Systematic mechanisms of capturing this information, such as by screening surveys, should be considered.
doi:10.1111/dme.12248
PMCID: PMC3748220  PMID: 23758145
21.  Early-pregnancy maternal vitamin D status and maternal hyperglycaemia 
Aims
To estimate the association between serum 25-hydroxyvitamin D concentrations and maternal hyperglycaemia (post-load glucose concentration ≥ 7.5 mmol/l).
Methods
Pregnant women (n = 429; 61% black, 36% obese, 45% smokers) enrolled in a cohort study at <16 weeks gestation. Non-fasting blood samples were assayed for serum 25-hydroxyvitamin D at enrolment. At 24–28 weeks gestation, maternal hyperglycaemia was determined using a 50-g 1-h oral glucose challenge test.
Results
A total of 67% of women had 25-hydroxyvitamin D concentrations < 50 nmol/l and 11% had maternal hyperglycaemia. Among smokers, each 23-nmol/l increase in serum 25-hydroxyvitamin D was associated with a reduction in the odds of maternal hyperglycaemia [odds ratio: 0.30 (95% CI: 0.13, 0.68)] after adjustment for parity, race/ethnicity, age, pre-pregnancy BMI, marital status, income, family history of diabetes, and gestational age of gestational diabetes mellitus screening. Among non-smokers, we found no association between early pregnancy vitamin D status and maternal hyperglycaemia.
Conclusions
Smoking status may modify the relationship between poor maternal vitamin D status and maternal hyperglycaemia.
doi:10.1111/dme.12229
PMCID: PMC3748256  PMID: 23668717
22.  A web-based pedometer program in women with recent histories of gestational diabetes 
Aims
Women with remote histories of gestational diabetes mellitus (GDM) can reduce their diabetes risk through lifestyle changes, but the effectiveness of interventions in women with more recent histories of GDM has not been reported. Therefore, we conducted a pilot study of a low-intensity web-based pedometer program targeting glucose intolerance among women with recent GDM.
Methods
Women with a GDM delivery within the past 3 years were randomized to a 13-week intervention consisting of a structured web-based pedometer program which gave personalized steps-per-week goals, pedometers, and education regarding lifestyle modification vs. a letter about diabetes risk reduction and screening after delivery for GDM (control condition). The main outcome measures were change in fasting plasma glucose (FPG) and 2-hour glucose levels on a 75-gram oral glucose tolerance test (OGTT) between baseline and 13-week follow-up. Weight was a secondary outcome and behavioural constructs (self-efficacy, social support, risk perception) were also assessed.
Results
Forty-nine women were enrolled. At 13 week follow-up, women randomized to the intervention did not have significant changesin behavioural constructs, physical activity, or anthropometrics compared to women in the control group. Changes in FPG(−0.046 mmol/lvs. 0.038 mmol/l, p=0.65), 2-hour glucose values (−0.48 mmol/l vs. −0.42 mmol/l, p=0.91)and weight (−0.14 kg vs. −1.5 kg, p=0.13)were similar between the control and intervention groups, respectively.
Conclusions
Structured web-based education utilizing pedometersis feasible although uptake may be low. Such programs may need to be supplemented with additional measures in order to be effective for reduction of diabetes risk.
doi:10.1111/j.1464-5491.2011.03415.x
PMCID: PMC4139030  PMID: 21838764
gestational diabetes; pedometers; physical activity; internet; intervention
23.  Liver enzymes, race, gender and diabetes risk: the Atherosclerosis Risk in Communities (ARIC) Study 
Aims
To examine the associations of the liver enzymes alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase with diabetes risk and to determine whether associations differ by race and/or gender. We hypothesized that all liver enzymes would be associated with diabetes risk and that associations would differ by race and gender.
Methods
Prospective cohort of 7495 white and 1842 black participants without diabetes in the Atherosclerosis Risk in Communities Study. Poisson and Cox models adjusted for demographic, socio-behavioural, and metabolic and health-related factors were used.
Results
During a median of 12 years of follow-up, 2182 incident cases of diabetes occurred. Higher liver enzyme levels were independently associated with diabetes risk: adjusted hazard ratios (95% confidence intervals) were 1.68 (1.49–1.89), 1.16 (1.02–1.31) and 1.95 (1.70–2.24) comparing the highest with the lowest quartiles of alanine aminotransferase, aspartate aminotransferase (AST) and gamma-glutamyl transferase (GGT), respectively. gamma-Glutamyl transferase was most strongly related to diabetes risk, even at levels considered within normal range (≤ 60 U/l) in clinical practice. Adjusted incidence rates by quartiles of liver enzymes were similar by gender but higher in black versus white participants. Nonetheless, relative associations of alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase (GGT) with diabetes were similar by race (P for interactions > 0.05).
Conclusions
Compared with aspartate aminotransferase and alanine aminotransferase, gamma-glutamyl transferase was more strongly associated with diabetes risk. Our findings suggest that abnormalities in liver enzymes precede the diagnosis of diabetes by many years and that individuals with elevated liver enzymes, even within the normal range as defined in clinical practice, are at high risk for diabetes.
doi:10.1111/dme.12187
PMCID: PMC3715563  PMID: 23510198
24.  Associations of blood glucose and prevalent diabetes with risk of cardiovascular disease in 500 000 adult Chinese: the China Kadoorie Biobank 
Diabetic Medicine  2014;31(5):540-551.
Abstract
Aims
To examine the relationship of self‐reported diabetes, and of random blood glucose levels among individuals without known diabetes, with the prevalence of cardiovascular disease in Chinese adults.
Methods
We examined cross‐sectional data from the China Kadoorie Biobank of 0.5 million people aged 30–79 years recruited from 10 diverse regions of China in the period 2004–2008. Logistic regression was used to estimate the odds ratios of prevalent cardiovascular disease associated with self‐reported diabetes, and with measured random blood glucose levels among participants with no history of diabetes, adjusting simultaneously for age, sex, area, education, smoking, alcohol, blood pressure and physical activity.
Results
A total of 3.2% of participants had self‐reported diabetes (men 2.9%; women 3.3%) and 2.8% had screen‐detected diabetes (men 2.6%; women 2.8%), i.e. they had no self‐reported history of diabetes but a blood glucose level suggestive of a diagnosis of diabetes. Compared with individuals without a history of diabetes, the odds ratios associated with self‐reported diabetes were 2.18 (95% CI 2.06–2.30) and 1.88 (95% CI 1.75–2.01) for prevalent ischaemic heart disease and stroke/transient ischaemic attack, respectively. Among participants without self‐reported diabetes there was a positive association between random blood glucose and ischaemic heart disease and stroke/transient ischaemic attack prevalence (P for trend <0.0001). Below the diabetic threshold (<11.1 mmol/l) each additional 1 mmol/l of random blood glucose was associated with 4% (95% CI 2–5%) and 5% (95% CI 3–7%) higher odds of prevalent ischaemic heart disease and stroke/transient ischaemic attack, respectively.
Conclusions
In this adult Chinese population, self‐reported diabetes was associated with a doubling of the odds of prevalent cardiovascular disease. Below the threshold for diabetes there was still a modest, positive association between random blood glucose and prevalent cardiovascular disease.
doi:10.1111/dme.12392
PMCID: PMC4114560  PMID: 24344928
25.  ‘COUGH-TRIGGERED’ TUBERCULOSIS SCREENING AMONG ADULTS WITH DIABETES IN TANZANIA 
Aims
Diabetes increases the risk of tuberculosis and the prevalence of diabetes is rising in tuberculosis-endemic regions such as sub-Saharan Africa. Resource-appropriate strategies for tuberculosis case finding among African adults with diabetes are needed. The aims of this study were to determine prevalence of tuberculosis and evaluate one screening strategy among adult Tanzanians with diabetes.
Methods
In this prospective cohort study, we evaluated a “cough-triggered” strategy for tuberculosis case finding among adults with diabetes at our zonal hospital in Tanzania. All adults with diabetes and cough underwent further tuberculosis symptom assessment and those with productive cough had sputum collected for microscopy and M. tuberculosis culture.
Results
Between September 2011 and March 2012, 700 adults with diabetes attended our hospital. A total of 693 were enrolled, 121/693 (17.5%) had cough and 32/693 (4.6%) had at least 2 of the classic symptoms of tuberculosis. Of note, 87/121 (71.9%) of patients with cough could not produce sputum spontaneously. Nine patients were diagnosed with tuberculosis for a prevalence of 1299/100,000 (1.3%), 7-fold greater than the national average.
Conclusions
Tuberculosis is common among Tanzanian adults with diabetes but tuberculosis case finding is challenging due to the high prevalence of non-productive cough. This low-cost, ‘cough-triggered’ tuberculosis case-finding strategy may serve as a reasonable first step for improving tuberculosis screening among adults with diabetes in sub-Saharan Africa.
doi:10.1111/dme.12348
PMCID: PMC4049009  PMID: 24152037

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