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1.  The En Balance Spanish Diabetes Education Program Improves Apolipoproteins, Serum Glucose and Body Composition in Hispanic Diabetics 
Ethnicity & disease  2012;22(2):215-220.
Objective
We evaluated the changes in apolipoproteins, glycemic status, and body composition after 3 months using a culturally sensitive diabetes education program, En Balance, in diabetic Hispanics.
Methods
Thirty-four (9 males, 25 females) Hispanic diabetics participated in the En Balance program over three months. Body composition was determined by dual energy X-ray absorptiometry (DXA), fasting plasma glucose (FPG), A1c, and apolipoproteins (Apo) measured after 3 months participation. Differences were analyzed using paired t testing and relationships between changes in Apo, A1c, total cholesterol, body mass index and body composition by Spearman correlations.
Results
Completion of En Balance resulted in a significant reduction in weight (80.31 ± 1.97 kg vs 81.25 ± 17.97 kg, P=.015), FPG (143.21 ± 57.8 mg/dL vs 166.41 ± 65.9 mg/dL P=.003), and A1c (7.08 ± 1.6% vs 7.87 ± 2.0%, P=<.001). DXA demonstrated reduction in total fat (29.54 ± 10.0 kg vs 30.24 ± 11.80 kg, P=<.001) and trunk fat (15.09 ± 5.6 kg vs 16.87 ± 5.4 kg, P=.001). High density lipoprotein significantly increased (48.85 ± 11.4 vs 44.65 ± 8.8, P=.002) and total serum cholesterol/high density lipoprotein ratio decreased (3.87 ± .98 vs 4.35 ± 1.0, P=.001). There were significant correlations at three months between changes in Apo A1 and A2 (r=.559, P<.001), Apo E and total cholesterol (r=.746, P<.001), between A1c and FPG (r=.563, P=.001) and BMI and body weight (r=.732, P<.001).
Conclusions
The En Balance program improved body composition, A1c, FPG, total cholesterol/HDL ratio and HDL. If these trends can be sustained, En Balance may serve as a unique educational paradigm for improving type 2 diabetes in Hispanics.
PMCID: PMC3894418  PMID: 22764645
Hispanics; Type 2 Diabetes; Diabetes Education Programs
2.  Improved Clinical Outcomes Using a Culturally Sensitive Diabetes Education Program in a Hispanic Population 
The Diabetes educator  2008;34(4):698-706.
Purpose
The purpose of this study was to evaluate the effects of a culturally sensitive diabetes education program for Hispanics with type 2 diabetes.
Methods
This study is a prospective cohort study to test the impact of a comprehensive diabetes education program on blood glucose control on Hispanics with type 2 diabetes. The educational program focused on maintaining glycemic control and general aspects of managing diabetes and complications. The study participants were recruited by flyers placed in Hispanic markets and in ambulatory care clinics. A total of 34 Hispanic male and female subjects with type 2 diabetes participated in the study. The concentrations of glucose, insulin, hemoglobin A1c (HbA1c), total cholesterol, triglycerides, low-density lipoprotein and high-density lipoprotein (HDL) cholesterol were analyzed at baseline and at 3 months.
Results
A significant mean change was observed for HbA1c, fasting plasma glucose, cholesterol/HDL ratio, and HDL after 3 months of education compared with baseline. There were significant reductions in weight, total fat, percent fat, trunk fat, and waist-to-hip ratio compared with baseline. After 3 months, subjects showed a significant positive correlation between changes in body mass index and insulin and weight, total fat, trunk fat, and fat free mass and insulin.
Conclusions
A culturally sensitive program conducted in Spanish had a significant impact on important clinical parameters in Hispanic subjects with diabetes in a relatively short time period. The study demonstrates the importance of designing education intervention studies that are sensitive to cultural diversity, particularly in at-risk diabetic subjects.
doi:10.1177/0145721708320913
PMCID: PMC2779017  PMID: 18669812
3.  Predicting the Glycemic Response to Gastric Bypass Surgery in Patients With Type 2 Diabetes 
Diabetes Care  2012;36(1):20-26.
OBJECTIVE
To find clinically meaningful preoperative predictors of diabetes remission and conversely inadequate glycemic control after gastric bypass surgery. Predicting the improvement in glycemic control in those with type 2 diabetes after bariatric surgery may help in patient selection.
RESEARCH DESIGN AND METHODS
Preoperative details of 154 ethnic Chinese subjects with type 2 diabetes were examined for their influence on glycemic outcomes at 1 year after gastric bypass. Remission was defined as HbA1c ≤6%. Analysis involved binary logistic regression to identify predictors and provide regression equations and receiver operating characteristic curves to determine clinically useful cutoff values.
RESULTS
Remission was achieved in 107 subjects (69.5%) at 12 months. Diabetes duration <4 years, body mass >35 kg/m2, and fasting C-peptide concentration >2.9 ng/mL provided three independent preoperative predictors and three clinically useful cutoffs. The regression equation classification plot derived from continuous data correctly assigned 84% of participants. A combination of two or three of these predictors allows a sensitivity of 82% and specificity of 87% for remission. Duration of diabetes (with different cutoff points) and C-peptide also predicted those cases in which HbA1c ≤7% was not attained. Percentage weight loss after surgery was also predictive of remission and of less satisfactory outcomes.
CONCLUSIONS
The glycemic response to gastric bypass is related to BMI, duration of diabetes, fasting C-peptide (influenced by insulin resistance and residual β-cell function), and weight loss. These data support and refine previous findings in non-Asian populations. Specific ethnic and procedural regression equations and cutoff points may vary.
doi:10.2337/dc12-0779
PMCID: PMC3526207  PMID: 23033249
4.  Structured Type 1 Diabetes Education Delivered Within Routine Care 
Diabetes Care  2013;36(2):270-272.
OBJECTIVE
To determine whether improvements in glycemic control and diabetes-specific quality of life (QoL) scores reported in research studies for the type 1 diabetes structured education program Dose Adjustment For Normal Eating (DAFNE) are also found when the intervention is delivered within routine U.K. health care.
RESEARCH DESIGN AND METHODS
Before and after evaluation of DAFNE to assess impact on glycemic control and QoL among 262 adults with type 1 diabetes.
RESULTS
There were significant improvements in HbA1c from baseline to 6 and 12 months (from 9.1 to 8.6 and 8.8%, respectively) in a subgroup with suboptimal control. QoL was significantly improved by 3 months and maintained at both follow-up points.
CONCLUSIONS
Longer-term improved glycemic control and QoL is achievable among adults with type 1 diabetes through delivery of structured education in routine care, albeit with smaller effect sizes than reported in trials.
doi:10.2337/dc12-0080
PMCID: PMC3554294  PMID: 23139374
5.  En Balance Participants Decrease Dietary Fat and Cholesterol Intake as Part of a Culturally Sensitive Hispanic Diabetes Education Program 
The Diabetes educator  2011;37(2):239-253.
Purpose
The purpose of this study was to assess dietary intake habits of Mexican American Hispanic adults participating in the En Balance diabetes education program.
Methods
En Balance is a 3-month culturally sensitive diabetes education intervention for Spanish-speaking Hispanics. Of the 46 participants enrolled, 39 mainly Mexican American Hispanic adults with type 2 diabetes completed the En Balance program. Participants lived in the Riverside and San Bernardino counties of California, and all participants completed the program by June 2008. Dietary intake was assessed at baseline and at 3 months using the validated Southwest Food Frequency Questionnaire.
Results
Clinically important decreases in glycemic control and serum lipid levels were observed at the end of the 3-month program. The baseline diet was characterized by a high intake of energy (2478 ± 1140 kcal), total fat (87 ± 44 g/day), saturated fat (28 ± 15 g/day), dietary cholesterol (338 ± 217 mg/day), and sodium (4236 ± 2055 mg/day). At 3 months, the En Balance group mean intake of dietary fat (P = .045) and dietary cholesterol (P = .033) decreased significantly. Low dietary intakes of docosahexaenoic acid, eicosapentaenoic acid, and vitamin E were also observed in these adults with type 2 diabetes.
Conclusions
The En Balance program improved glycemic control and lipid profiles in a group of Hispanic diabetic participants. En Balance also promoted decreases in dietary fat and dietary cholesterol intake.
doi:10.1177/0145721710394874
PMCID: PMC3062643  PMID: 21343598
6.  Cross-sectional and longitudinal relationships of body mass index with glycemic control in children and adolescents with type 1 diabetes mellitus 
Aims
Weight gain is an oft-cited outcome of improved glycemic control in adults with type 1 diabetes, though few studies have investigated this in youth. The purpose of this paper was to examine cross-sectional and longitudinal associations of body mass index (BMI, kg/m2) with glycemic control in youth with type 1 diabetes (n=340, 12.5±1.7y, 49% female, duration ≥1year) participating in a 2-year multicenter intervention study targeting family diabetes management.
Methods
BMI was calculated from height and weight measured at clinic visits. Glycohemoglobin (HbA1c) at each visit was assayed centrally. Cross-sectional associations of baseline BMI with glycemic control, and of change in BMI and HbA1c with baseline values, were examined. Longitudinal associations of time-varying BMI and HbA1c were examined using a multilevel linear mixed effects model controlling for time-varying time (months), insulin dose (units/kg/day), regimen, Tanner stage, and time invariant baseline diabetes duration, BMI, treatment group and sociodemographic characteristics.
Results
Baseline HbA1c was unrelated to baseline BMI, but was related positively to subsequent BMI change (p=0.04) and inversely to HbA1c change (p=0.002). Baseline BMI was inversely related to BMI change (p=0.01) and unrelated to HbA1c change. In multilevel regression, BMI was related inversely to HbA1c (%) (β±SE=−0.11±0.02,p<0.001) and positively to insulin dose (0.23±0.07,p=0.001). In the treatment group only, BMI was positively related to pump regimen (0.18±0.08,p=0.02).
Conclusions
Increased insulin administered to improve glycemic control may contribute to increased BMI in youth with type 1 diabetes, indicating the importance of determining ways to minimize weight gain while optimizing glycemic control.
doi:10.1016/j.diabres.2012.12.025
PMCID: PMC3634913  PMID: 23339757
BMI; children; adolescents; longitudinal
7.  Effects of Exercise on Cardiovascular Risk Factors in Type 2 Diabetes 
Diabetes Care  2011;34(5):1228-1237.
OBJECTIVE
Exercise is a cornerstone of diabetes management and the prevention of incident diabetes. However, the impact of the mode of exercise on cardiovascular (CV) risk factors in type 2 diabetes is unclear.
RESEARCH DESIGN AND METHODS
We conducted a systematic review of the literature between 1970 and October 2009 in representative databases for the effect of aerobic or resistance exercise training on clinical markers of CV risk, including glycemic control, dyslipidemia, blood pressure, and body composition in patients with type 2 diabetes.
RESULTS
Of 645 articles retrieved, 34 met our inclusion criteria; most investigated aerobic exercise alone, and 10 reported combined exercise training. Aerobic alone or combined with resistance training (RT) significantly improved HbA1c −0.6 and −0.67%, respectively (95% CI −0.98 to −0.27 and −0.93 to −0.40, respectively), systolic blood pressure (SBP) −6.08 and −3.59 mmHg, respectively (95% CI −10.79 to −1.36 and −6.93 to −0.24, respectively), and triglycerides −0.3 mmol/L (95% CI −0.48 to −0.11 and −0.57 to −0.02, respectively). Waist circumference was significantly improved −3.1 cm (95% CI −10.3 to −1.2) with combined aerobic and resistance exercise, although fewer studies and more heterogeneity of the responses were observed in the latter two markers. Resistance exercise alone or combined with any other form of exercise was not found to have any significant effect on CV markers.
CONCLUSIONS
Aerobic exercise alone or combined with RT improves glycemic control, SBP, triglycerides, and waist circumference. The impact of resistance exercise alone on CV risk markers in type 2 diabetes remains unclear.
doi:10.2337/dc10-1881
PMCID: PMC3114506  PMID: 21525503
8.  Does Glycemic Variability Impact Mood and Quality of Life? 
Abstract
Background
Diabetes is a chronic condition that significantly impacts quality of life. Poor glycemic control is associated with more diabetes complications, depression, and worse quality of life. The impact of glycemic variability on mood and quality of life has not been studied.
Methods
A descriptive exploratory design was used. Twenty-three women with type 2 diabetes wore a continuous glucose monitoring system for 72 h and completed a series of questionnaires. Measurements included (1) glycemic control shown by glycated hemoglobin and 24-h mean glucose, (2) glycemic variability shown by 24-h SD of the glucose readings, continuous overall net glycemic action (CONGA), and Fourier statistical models to generate smoothed curves to assess rate of change defined as “energy,” and (3) mood (depression, anxiety, anger) and quality of life by questionnaires.
Results
Women with diabetes and co-morbid depression had higher anxiety, more anger, and lower quality of life than those without depression. Certain glycemic variability measures were associated with mood and quality of life. The 24-h SD of the glucose readings and the CONGA measures were significantly associated with health-related quality of life after adjusting for age and weight. Fourier models indicated that certain energy components were significantly associated with depression, trait anxiety, and overall quality of life. Finally, subjects with higher trait anxiety tended to have steeper glucose excursions.
Conclusions
Data suggest that greater glycemic variability may be associated with lower quality of life and negative moods. Implications include replication of the study in a larger sample for the assessment of blood glucose fluctuations as they impact mood and quality of life.
doi:10.1089/dia.2011.0191
PMCID: PMC3317401  PMID: 22324383
9.  Managing the Space between Visits: A Randomized Trial of Disease Management for Diabetes in a Community Health Center 
Journal of General Internal Medicine  2010;25(10):1116-1122.
Background
Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients.
Objective
We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center.
Design
Randomized controlled trial.
Participants
All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured.
Measurements
Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity.
Results
A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity.
Conclusions
A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.
doi:10.1007/s11606-010-1419-5
PMCID: PMC2955486  PMID: 20556536
diabetes; self-management; telehealth; disease management; community health centers; Hispanic Americans
10.  Plasma adipokine and inflammatory marker concentrations are altered in obese, as opposed to non-obese, type 2 diabetes patients 
Elevated plasma free fatty acid (FFA), inflammatory marker, and altered adipokine concentrations have been observed in obese type 2 diabetes patients. It remains unclear whether these altered plasma concentrations are related to the diabetic state or presence of obesity. In this cross-sectional observational study, we compare basal plasma FFA, inflammatory marker, and adipokine concentrations between obese and non-obese type 2 diabetes patients and healthy, non-obese controls. A total of 20 healthy, normoglycemic males (BMI <30 kg/m2), 20 non-obese (BMI <30 kg/m2) and 20 obese (BMI >35 kg/m2) type 2 diabetes patients were selected to participate in this study. Groups were matched for age and habitual physical activity level. Body composition, glycemic control, and exercise performance capacity were assessed. Basal blood samples were collected to determine plasma leptin, adiponectin, resistin, tumor necrosis factor α (TNFα), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP) and FFA concentrations. Plasma FFA, inflammatory marker (hsCRP, IL-6, TNFα), adipokine (adiponectin, resistin, leptin), and triglyceride concentrations did not differ between non-obese diabetes patients and healthy, normoglycemic controls. Plasma FFA, IL-6, hsCRP, leptin, and triglyceride levels were significantly higher in the obese diabetes patients when compared with the healthy normoglycemic controls (P < 0.05). Furthermore, plasma hsCRP and leptin levels were significantly higher in the obese versus non-obese diabetes patients (P < 0.05). Significant correlations between plasma parameters and glycemic control were observed, but disappeared after adjusting for trunk adipose tissue mass. Elevated plasma leptin, hsCRP, IL-6, and FFA concentrations are associated with obesity and not necessarily with the type 2 diabetic state.
doi:10.1007/s00421-010-1362-5
PMCID: PMC2874484  PMID: 20131064
Obesity; Diabetes; Adipokines; Inflammation; Fat mass
11.  Circuit Resistance Exercise Improves Glycemic Control and Adipokines in Females with Type 2 Diabetes Mellitus 
The aim of study was to evaluate whether circuit resistance exercise (CE) improves glycemic control and adipokine levels in comparison with walking exercise (WE) in 15 adult postmenopausal Korean females with type 2 diabetes mellitus (T2DM). The participants were randomly assigned to either the CE or WE group. Subjects exercised for 1 h, three times per week for 12 weeks. The parameters measured were body composition, respiratory rate, blood glucose, insulin and adipokines. The body composition of the CE group showed a significant reduction (all p < 0.05) in body weight, body mass index (BMI), and percentage of body fat and a significant increase in muscle mass. Respiratory function was also significantly increased in the CE group. Additionally, hemoglobin A1c (HbA1c) changed favorably in the CE group, as were the concentrations of adipokines such as retinol binding protein 4 (RBP-4) (p < 0.05), adiponectin (p < 0.01), and monocyte chemoattractant protein-1 (MCP-1) (p < 0.01). In addition, significant correlations with CE were evident for homeostatic model assessment insulin resistance (HOMA-IR) and glucose (r = 0.69, p < 0.001), muscle mass and glucose (r = 0.45, p < 0.05), and muscle mass and HbA1c (r = 0.39, p < 0.05). The beneficial effects of CE include the development of muscle mass, which effectively increases glucose use and reduces the amount of insulin required. Thus, our results suggest that CE improves glycemic control and adipokines resulting from incrementally increased muscle mass and reductions of body weight, BMI and percentage of body fat for T2DM postmenopausal Korean women.
Key pointsCE-induced weight loss and muscle mass increment increases the level of adiponectin secreted by adipocytes due to heightened glucose utilization and fat oxidation.Aerobic exercise decreases body weight, fat and adipokines in high intensity and frequency, while resistance exercise decreases these parameters in low intensity, time and frequency.CE can improves glycemic control and adipokines resulting from reduction of body fat postmenopausal Korean women with T2DM.
PMCID: PMC3761547  PMID: 24149611
Circuit resistance exercise; walking exercise; glycemic control; adipokines, type 2 diabetes.
12.  Interventions With Adherence-Promoting Components in Pediatric Type 1 Diabetes 
Diabetes Care  2010;33(7):1658-1664.
OBJECTIVE
To review interventions with adherence-promoting components and document their impact on glycemic control via meta-analysis.
RESEARCH DESIGN AND METHODS
Data from 15 studies that met the following criteria were subjected to meta-analysis: 1) randomized, controlled trial, 2) study sample included youth aged <19 years, 3) youth had type 1 diabetes, 4) study reported results on glycemic control; and 5) study reported use of adherence- or self-management–promoting components.
RESULTS
The 15 studies included 997 youth with type 1 diabetes. The mean effect size for pre- to posttreatment change for the intervention versus control group comparison was 0.11 (95% CI −0.01 to 0.23). This is a small effect, demonstrating very modest improvements in glycemic control. However, analysis for the pre- to posttreatment effects for the intervention group alone did show significant variability [Q(14) = 33.11; P < 0.05]. Multicomponent interventions, those that targeted emotional, social, or family processes that facilitate diabetes management, were more potent than interventions just targeting a direct, behavioral process (e.g., increase in blood glucose monitoring frequency).
CONCLUSIONS
Interventions that focus on direct, behavioral processes and neglect emotional, social, and family processes are unlikely to have an impact on glycemic control; multicomponent interventions showed more robust effects on A1C. Future clinical research should focus on refining interventions and gathering more efficacy and effectiveness data on health outcomes of the pediatric patients treated with these interventions.
doi:10.2337/dc09-2268
PMCID: PMC2890378  PMID: 20587726
13.  The effect of a low-carbohydrate, ketogenic diet versus a low-glycemic index diet on glycemic control in type 2 diabetes mellitus 
Objective
Dietary carbohydrate is the major determinant of postprandial glucose levels, and several clinical studies have shown that low-carbohydrate diets improve glycemic control. In this study, we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus.
Research design and methods
Eighty-four community volunteers with obesity and type 2 diabetes were randomized to either a low-carbohydrate, ketogenic diet (<20 g of carbohydrate daily; LCKD) or a low-glycemic, reduced-calorie diet (500 kcal/day deficit from weight maintenance diet; LGID). Both groups received group meetings, nutritional supplementation, and an exercise recommendation. The main outcome was glycemic control, measured by hemoglobin A1c.
Results
Forty-nine (58.3%) participants completed the study. Both interventions led to improvements in hemoglobin A1c, fasting glucose, fasting insulin, and weight loss. The LCKD group had greater improvements in hemoglobin A1c (-1.5% vs. -0.5%, p = 0.03), body weight (-11.1 kg vs. -6.9 kg, p = 0.008), and high density lipoprotein cholesterol (+5.6 mg/dL vs. 0 mg/dL, p < 0.001) compared to the LGID group. Diabetes medications were reduced or eliminated in 95.2% of LCKD vs. 62% of LGID participants (p < 0.01).
Conclusion
Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes. The diet lower in carbohydrate led to greater improvements in glycemic control, and more frequent medication reduction/elimination than the low glycemic index diet. Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes.
doi:10.1186/1743-7075-5-36
PMCID: PMC2633336  PMID: 19099589
14.  Adherence and Glycemic Control among Hispanic Youth with Type 1 Diabetes: Role of Family Involvement and Acculturation 
Journal of Pediatric Psychology  2009;35(2):156-166.
Objective To assess whether family involvement and acculturation were related to adherence and glycemic control among Hispanic youth with type 1 diabetes (T1D). Methods Hispanic youth with T1D (n = 111; M age = 13.33; 53% female) and parents completed questionnaires that assessed diabetes-related family involvement (distribution of responsibility for diabetes, family support for diabetes), acculturation (linguistic acculturation, generational status), and adherence. HbA1c levels indexed glycemic control. Results Better adherence was associated with less adolescent independent responsibility, more family support for diabetes, and more recent immigration (fewer generations of the family living in US). Family support mediated the relationship between responsibility and adherence. Better glycemic control was associated with higher levels of parental education and adherence. Conclusions Family support for diabetes is important for adherence among Hispanic youth with T1D. Research should examine aspects of recent immigration that contribute to better adherence and the impact of supportive interventions on diabetes care.
doi:10.1093/jpepsy/jsp045
PMCID: PMC2821010  PMID: 19491214
diabetes; adolescents; youth; acculturation; family; social support; adherence; glycemic control; Hispanic.
15.  Quantifying the Effect of Metformin Treatment and Dose on Glycemic Control 
Diabetes Care  2012;35(2):446-454.
OBJECTIVE
Metformin is the first-line oral medication recommended for glycemic control in patients with type 2 diabetes. We reviewed the literature to quantify the effect of metformin treatment on glycated hemoglobin (HbA1c) levels in all types of diabetes and examine the impact of differing doses on glycemic control.
RESEARCH DESIGN AND METHODS
MEDLINE, EMBASE, and the Cochrane Library were searched from 1950 to June 2010 for trials of at least 12 weeks’ duration in which diabetic patients were treated with either metformin monotherapy or as an add-on therapy. Data on change in HbA1c were pooled in a meta-analysis. Data from dose-comparison trials were separately pooled.
RESULTS
A total of 35 trials were identified for the main analysis and 7 for the dose-comparison analysis. Metformin monotherapy lowered HbA1c by 1.12% (95% CI 0.92–1.32; I2 = 80%) versus placebo, metformin added to oral therapy lowered HbA1c by 0.95% (0.77–1.13; I2 = 77%) versus placebo added to oral therapy, and metformin added to insulin therapy lowered HbA1c by 0.60% (0.30–0.91; I2 = 79.8%) versus insulin only. There was a significantly greater reduction in HbA1c using higher doses of metformin compared with lower doses of metformin with no significant increase in side effects.
CONCLUSIONS
Evidence supports the effectiveness of metformin therapy in a clinically important lowering of HbA1c used as monotherapy and in combination with other therapeutic agents. There is potential for using higher doses of metformin to maximize glycemic control in diabetic patients without increasing gastrointestinal effects.
doi:10.2337/dc11-1465
PMCID: PMC3263873  PMID: 22275444
16.  Effect of Computer-Generated Tailored Feedback on Glycemic Control in People With Diabetes in the Community 
Diabetes Care  2011;34(8):1794-1798.
OBJECTIVE
It is unknown whether computer-generated, patient-tailored feedback leads to improvements in glycemic control in people with type 2 diabetes.
RESEARCH DESIGN AND METHODS
We recruited people with type 2 diabetes aged ≥40 years with a glycated hemoglobin (A1C) ≥7%, living in Hamilton, Canada, who were enrolled in a community-based program (Diabetes Hamilton) that provided regular evidence-based information and listings of community resources designed to facilitate diabetes self-management. After completing a questionnaire, participants were randomly allocated to either receive or not receive periodic computer-generated, evidence-based feedback on the basis of their questionnaire responses and designed to facilitate improved glycemic control and diabetes self-management. The primary outcome was a change in A1C after 1 year.
RESULTS
A total of 465 participants (50% women, mean age 62 years, and mean A1C 7.83%) were randomly assigned, and 12-month A1C values were available in 96% of all participants, at which time the A1C level had decreased by an absolute amount of 0.24 and 0.15% in the intervention and control groups, respectively. The difference in A1C reduction for the intervention versus control group was 0.09% (95% CI −0.08 to 0.26; P = 0.3). No between-group differences in measures of quality of life, diabetes self-management behaviors, or clinical outcomes were observed.
CONCLUSIONS
Providing computer-generated tailored feedback to registrants of a generic, community-based program that supports diabetes self-management does not lead to lower A1C levels or a better quality of life than participation in the community-based program (augmented by periodic A1C testing) alone.
doi:10.2337/dc11-0006
PMCID: PMC3142042  PMID: 21680723
17.  COH-SR4 Reduces Body Weight, Improves Glycemic Control and Prevents Hepatic Steatosis in High Fat Diet-Induced Obese Mice 
PLoS ONE  2013;8(12):e83801.
Obesity is a chronic metabolic disorder caused by imbalance between energy intake and expenditure, and is one of the principal causative factors in the development of metabolic syndrome, diabetes and cancer. COH-SR4 (“SR4”) is a novel investigational compound that has anti-cancer and anti-adipogenic properties. In this study, the effects of SR4 on metabolic alterations in high fat diet (HFD)-induced obese C57BL/J6 mice were investigated. Oral feeding of SR4 (5 mg/kg body weight.) in HFD mice for 6 weeks significantly reduced body weight, prevented hyperlipidemia and improved glycemic control without affecting food intake. These changes were associated with marked decreases in epididymal fat mass, adipocyte hypertrophy, increased plasma adiponectin and reduced leptin levels. SR4 treatment also decreased liver triglycerides, prevented hepatic steatosis, and normalized liver enzymes. Western blots demonstrated increased AMPK activation in liver and adipose tissues of SR4-treated HFD obese mice, while gene analyses by real time PCR showed COH-SR4 significantly suppressed the mRNA expression of lipogenic genes such as sterol regulatory element binding protein-1c (Srebf1), acetyl-Coenzyme A carboxylase (Acaca), peroxisome proliferator-activated receptor gamma (Pparg), fatty acid synthase (Fasn), stearoyl-Coenzyme A desaturase 1 (Scd1), carnitine palmitoyltransferase 1a (Cpt1a) and 3-hydroxy-3-methyl-glutaryl-CoA reductase (Hmgcr), as well as gluconeogenic genes phosphoenolpyruvate carboxykinase 1 (Pck1) and glucose-6-phosphatase (G6pc) in the liver of obese mice. In vitro, SR4 activates AMPK independent of upstream kinases liver kinase B1 (LKB1) and Ca2+/calmodulin-dependent protein kinase kinase β (CaMKKβ). Together, these data suggest that SR4, a novel AMPK activator, may be a promising therapeutic compound for treatment of obesity, fatty liver disease, and related metabolic disorders.
doi:10.1371/journal.pone.0083801
PMCID: PMC3869817  PMID: 24376752
18.  Effect of Caloric Intake 25 or 30 kcal/kg/day on the Glycemic Control in Obese Patients With Type 2 Diabetes 
Background
The recommended total dietary energy intake prescribed medical nutrition therapy for obese or overweight patients with type 2 diabetes in Japan is often set at 25 kcal/kg ideal body weight (IBW)/day. This study was conducted to determine the impact of the total dietary energy intake (25 or 30 kcal/kg IBW/day) on the glycemic control, lipid profile, and satisfaction level in overweight patients with type 2 diabetes.
Methods
We performed interview and a designed prospective, randomized, controlled, multicenter study trial. Recruitment for interview for doctors and hospitalization of the obese or overweight patients with type 2 diabetes began from September 2008 and continued until June 2010. The subjects were randomly assigned to 25 kcal/kg IBW/day group (25 kcal group) or 30 kcal/kg IBW/day group (30 kcal group). The primary endpoint was the body weight of the subjects at the time of hospitalization, at the time of discharge from the hospital, and at 3, 6 and 12 months after discharge from the hospital.
Results
The glycemic control, lipid control and body weight were similar between the 25 and 30 kcal groups during the 12-month follow-up, and the degree of satisfaction in respect of the medical treatment was significantly higher in the 30 kcal group than in the 25 kcal group at 1 year after discharge.
Conclusions
It is considered to be preferable for the caloric intake to be set at 30kcal/kg IBW/day rather than at 25 kcal/kg IBW/day for obese or overweight patients with type 2 diabetes.
doi:10.4021/jocmr1488w
PMCID: PMC3748661  PMID: 23976909
Diabetes mellitus; Obesity therapy; Nutrition; Energy regulation
19.  Convergence of obesity and high glycemic diet on compounding diabetes and cardiovascular risks in modernizing China: An emerging public health dilemma 
As China is undergoing dramatic development, it is also experiencing major societal changes, including an emerging obesity epidemic, with the prevalence of overweight and obesity doubling in the past decade. However, the implications of a high glycemic index (GI) and glycemic load (GL) traditional Chinese diet are adversely changing in modern times, as a high-glycemic diet is becoming a greater contributor to diabetes and cardiovascular risks in a population with rising obesity and decreasing physical activity. Specifically, a high GI diet adversely impacts metabolism and appetite control regulation, and notably confers substantially greater risk of weight gain, type 2 diabetes, cardiovascular disease, and certain cancers among overweight and obese individuals (P<0.05 for all); leading to an emerging vicious cycle of compounding adverse health risks. Notably, while no elevated risk of cardiovascular disease and type 2 diabetes were observed with higher GL intake among normal weight individuals, among overweight individuals, higher GL was strongly associated with higher risk of coronary heart disease (RR=2.00, 95%CI: 1.31-2.96), stroke (RR=2.13, 1.28-3.53), and type 2 diabetes (RR=1.52, 1.22-1.89 among Chinese). Additionally, the influx of Western-diets rich in saturated fats and high-glycemic sugar-sweetened beverages also threaten the health of the population. This review highlights the emerging adverse convergence of a high-glycemic Asian diet with a Chinese society experiencing an emerging obesity epidemic, and the important implications of these combined factors on compounding cardiometabolic risks. Potential policy directions in China are also discussed.
doi:10.1186/1744-8603-4-4
PMCID: PMC2292178  PMID: 18302739
20.  Predictors of glycemic control among patients with Type 2 diabetes: A longitudinal study 
BMC Public Health  2005;5:36.
Background
Diabetes is the sixth leading cause of death and results in significant morbidity. The purpose of this study is to determine what demographic, health status, treatment, access/quality of care, and behavioral factors are associated with poor glycemic control in a Type 2 diabetic, low-income, minority, San Diego population.
Methods
Longitudinal observational data was collected on patients with Type 2 diabetes from Project Dulce, a program in San Diego County designed to care for an underserved diabetic population. The study sample included 573 patients with a racial/ethnic mix of 53% Hispanic, 7% black, 18% Asian, 20% white, and 2% other. We utilized mixed effects models to determine the factors associated with poor glycemic control using hemoglobin A1C (A1C) as the outcome of interest. A multi-step model building process was used resulting in a final parsimonious model with main effects and interaction terms.
Results
Patients had a mean age of 55 years, 69% were female, the mean duration of diabetes was 7.1 years, 31% were treated with insulin, and 57% were obese. American Diabetes Association (ADA) recommendations for blood pressure and total cholesterol were met by 71% and 68%, respectively. Results of the mixed effects model showed that patients who were uninsured, had diabetes for a longer period of time, used insulin or multiple oral agents, or had high cholesterol had higher A1C values over time indicating poorer glycemic control. The younger subjects also had poorer control.
Conclusion
This study provides factors that predict glycemic control in a specific low-income, multiethnic, Type 2 diabetic population. With this information, subgroups with high risk of disease morbidity were identified. Barriers that prevent these patients from meeting their goals must be explored to improve health outcomes.
doi:10.1186/1471-2458-5-36
PMCID: PMC1090595  PMID: 15833140
21.  A randomized controlled trial to prevent glycemic relapse in longitudinal diabetes care: Study protocol (NCT00362193) 
Background
Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors.
Objective
This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline.
Methods
The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive), routine care with phone contact every three months (moderate intensity) or routine care with phone contact every month (most intensive).
Conclusion
The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.
doi:10.1186/1748-5908-1-24
PMCID: PMC1634866  PMID: 17054790
22.  Effect of glycemic control on periodontitis in type 2 diabetic patients with periodontal disease 
Aims/Introduction
Diabetes mellitus and periodontitis are closely related. A huge number of reports has addressed the effect of periodontal intervention therapy on glycemic control, but no reports have addressed the effect of glycemic intervention therapy on periodontal disease in type 2 diabetic patients. The aim of this study was to examine the effect of improved glycemic control by glycemic intervention therapy on periodontitis in type 2 diabetic patients.
Materials and Methods
A total of 35 patients underwent intervention therapy to improve glycemic control without periodontal treatment. Glycohemoglobin (HbA1c), high-sensitivity C-reactive protein (hs-CRP), bleeding on probing (BOP), probing pocket depth (PPD) and intraoral community periodontal index (CPI) codes of the World health Organization (WHO) were examined at baseline, and 2 and 6 months after the intervention therapy to improve glycemic control.
Results
After the improvement of glycemic control, BOP lesions improved, but deep PPD lesions and WHO CPI codes did not improve. Subanalyses showed that effective glycemic control (average HbA1c reduction 1.8%) improved BOP lesions, but did not affect deep PPD lesions and WHO CPI codes. In addition, high BOP lesions at baseline responded more effectively to glycemic intervention. Further analysis of CPI codes in all individual periodontal sites independent of WHO CPI codes in 35 patients showed that only gingival inflammation without a deep periodontal pocket improved after glycemic intervention.
Conclusions
Effective glycemic control improves BOP lesions in type 2 diabetic patients with periodontitis through ameliorating inflammation at the gingival sites of periodontal tissue. This trial was registered with the University Hospital Medical Information Network (no. UMIN000007670).
doi:10.1111/jdi.12026
PMCID: PMC3752968  PMID: 23997922
Bleeding on probing; Periodontitis; Type 2 diabetes intervention therapy
23.  Exercise Therapy in Type 2 Diabetes 
Diabetes Care  2012;35(5):948-954.
OBJECTIVE
Given the transient nature of exercise-induced improvements in insulin sensitivity, it has been speculated that daily exercise is preferred to maximize the benefits of exercise for glycemic control. The current study investigates the impact of daily exercise versus exercise performed every other day on glycemic control in type 2 diabetic patients.
RESEARCH DESIGN AND METHODS
Thirty type 2 diabetic patients (age 60 ± 1 years, BMI 30.4 ± 0.7 kg/m2, and HbA1c 7.2 ± 0.2%) participated in a randomized crossover experiment. Subjects were studied on three occasions for 3 days under strict dietary standardization but otherwise free-living conditions. Blood glucose homeostasis was assessed by continuous glucose monitoring over 48 h during which subjects performed no exercise (control) or 60 min of cycling exercise (50% maximal workload capacity) distributed either as a single session performed every other day or as 30 min of exercise performed daily.
RESULTS
The prevalence of hyperglycemia (blood glucose >10 mmol/L) was reduced from 7:40 ± 1:00 h:min per day (32 ± 4% of the time) to 5:46 ± 0:58 and 5:51 ± 0:47 h:min per day, representing 24 ± 4 and 24 ± 3% of the time, when exercise was performed either daily or every other day, respectively (P < 0.001 for both treatments). No differences were observed between the impact of daily exercise and exercise performed every other day.
CONCLUSIONS
A short 30-min session of moderate-intensity endurance-type exercise substantially reduces the prevalence of hyperglycemia throughout the subsequent day in type 2 diabetic patients. When total work is being matched, daily exercise does not further improve daily glycemia compared with exercise performed every other day.
doi:10.2337/dc11-2112
PMCID: PMC3329820  PMID: 22399700
24.  Diabetes-Specific Nutrition Algorithm: A Transcultural Program to Optimize Diabetes and Prediabetes Care 
Current Diabetes Reports  2012;12(2):180-194.
Type 2 diabetes (T2D) and prediabetes have a major global impact through high disease prevalence, significant downstream pathophysiologic effects, and enormous financial liabilities. To mitigate this disease burden, interventions of proven effectiveness must be used. Evidence shows that nutrition therapy improves glycemic control and reduces the risks of diabetes and its complications. Accordingly, diabetes-specific nutrition therapy should be incorporated into comprehensive patient management programs. Evidence-based recommendations for healthy lifestyles that include healthy eating can be found in clinical practice guidelines (CPGs) from professional medical organizations. To enable broad implementation of these guidelines, recommendations must be reconstructed to account for cultural differences in lifestyle, food availability, and genetic factors. To begin, published CPGs and relevant medical literature were reviewed and evidence ratings applied according to established protocols for guidelines. From this information, an algorithm for the nutritional management of people with T2D and prediabetes was created. Subsequently, algorithm nodes were populated with transcultural attributes to guide decisions. The resultant transcultural diabetes-specific nutrition algorithm (tDNA) was simplified and optimized for global implementation and validation according to current standards for CPG development and cultural adaptation. Thus, the tDNA is a tool to facilitate the delivery of nutrition therapy to patients with T2D and prediabetes in a variety of cultures and geographic locations. It is anticipated that this novel approach can reduce the burden of diabetes, improve quality of life, and save lives. The specific Southeast Asian and Asian Indian tDNA versions can be found in companion articles in this issue of Current Diabetes Reports.
doi:10.1007/s11892-012-0253-z
PMCID: PMC3303078  PMID: 22322477
Diabetes; Diet; Glycemic control; Nutrition; Transcultural; Prediabetes
25.  Prevalence of Undiagnosed and Suboptimally Controlled Diabetes by Point-of-care HbA1C in Unselected Emergency Department Patients 
Objectives
The objective was to estimate the glycemic control of patients with known diabetes and to assess the prevalence of undiagnosed diabetes in an unselected emergency department (ED) population. Secondary objectives include evaluating the prevalence of undiagnosed diabetes in high-risk groups of ED patients such as Hispanic patients, African Americans, and patients with body mass index (BMI) ≥ 30 kg/m2.
Methods
A convenience sample of adult ED patients was screened for diabetes using a National Glyco-hemoglobin Standardization Program–certified point-of-care (POC) glycated hemoglobin (HbA1C) meter at a single academic medical center during eight 24-hour periods. Diabetes was defined as HbA1C ≥ 6.5%, consistent with new American Diabetes Association (ADA) guidelines.
Results
Of the 1,611 patients evaluated in the ED during the study period, 313 were included in the study sample. Of these, 15% reported a history of diabetes, 42% of whom were suboptimally controlled. An additional 14% of the study sample was found to have previously undiagnosed diabetes. In our limited sample, the prevalence of previously undiagnosed diabetes in Hispanics, African Americans, and patients with BMI ≥ 30 kg/m2 was 14, 27, and 22%, respectively.
Conclusions
Patients in our sample had a high prevalence of suboptimally controlled and undiagnosed diabetes. New POC HbA1C devices and simplified diagnostic criteria for diabetes significantly enhance the possibility of ED-based screening programs. Future research should validate our findings in a broader array of EDs and study the acceptance of such ED-based diabetes screening programs.
doi:10.1111/j.1553-2712.2011.01014.x
PMCID: PMC3529908  PMID: 21362098

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