BACKGROUND

Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery.

METHODS

In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49 ± 8 years, and 66% were women. The average glycated hemoglobin level was 9.2 ± 1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment.

RESULTS

Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P = 0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P = 0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5 ± 1.8% in the medical-therapy group, 6.4 ± 0.9% in the gastric-bypass group (P<0.001), and 6.6 ± 1.0% in the sleeve-gastrectomy group (P = 0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (−29.4 ± 9.0 kg and −25.1 ± 8.5 kg, respectively) than in the medical-therapy group (−5.4 ± 8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications.

CONCLUSIONS

In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.)

Bariatric/metabolic surgery is considered an accepted treatment option for type 2 diabetes mellitus (T2DM) with body mass index (BMI)  ≧  35 kg/m2. Mounting evidence also shows that metabolic surgery is effective for T2DM with BMI  <  35 kg/m2. To evaluate current status of metabolic surgery, we reviewed the available clinical studies which described surgical treatment for T2DM with mean BMI  <  35 kg/m2. 18 studies with 477 patients were identified. 30% of the patients was insulin users. The follow-up period ranged from 6 to 216 months. The weight loss effect was reasonable, not excessive. Mean BMI decreased from 30.4 to 24.8 kg/m2. Remission of T2DM was achieved in 64.7% of the patients with fasting plasma glucose and glycated hemoglobin approaching slightly above normal range. Clinical T2DM status was an important factor when selecting the eligible candidates for metabolic surgery. Postoperative complication rate of 10.3% with mortality of 0% in the studies has been acceptable. Even though it would be premature at this point to state that metabolic surgery is an accepted treatment option for T2DM with BMI < 35 kg/m2, it is clear that a high proportion of T2DM patients will derive substantial benefit from metabolic surgery.

Background

Altered cytokine secretion from dysfunctional adipose tissue or “adiposopathy” is implicated in obesity related inflammation and may mediate reduced CVD risk in response to weight loss after bariatric surgery. We hypothesized that bariatric surgery reduces CVD risk by favorably altering the pro-inflammatory profile of adipose tissue as a result of weight loss.

Methods

In this observational study with repeated measures, 142 patients underwent bariatric surgery of which 45 returned for follow up at ~6 months. At both time-points, lipid profiles and levels of plasma adiponectin, leptin, and TNF-α were obtained. Ratios of various adipokine parameters were related to pre- and post- surgical (gastric bypass vs. other restrictive bariatric procedures) lipid ratios.

Results

Prior to surgery, circulating adiponectin and the adiponectin/TNF-α ratio was strongly associated with CVD risk characterized by levels of triglycerides, HDL, and the TC/HDL, LDL/HDL and TG/HDL ratios (all P < 0.05). Following bariatric surgery, BMI was decreased by 22%, adiponectin was increased by 93%, and leptin decreased by 50% as compared to baseline (all P < 0.01). TNF-α levels increased by 120% (P < 0.01) following surgery. Post-surgical changes in adiponectin and the leptin/adiponectin ratio were strongly associated with incremental improvements in triglycerides, HDL, and TC/HDL, LDL/HDL and TG/HDL ratios (all P < 0.05). Roux-en-y gastric bypass surgery (RYGB) as compared to other bariatric procedures was associated with more robust improvements in BMI, HDL, and leptin/adiponectin ratio than other gastric restrictive procedures (P < 0.05).

Conclusions

Thus, bariatric surgery, especially RYGB, ameliorates CVD risk through a partial recovery from “adiposopathy”, distinctively characterized by improved adiponectin and the leptin/adiponectin ratio.

Background

Microalbuminuria portends an increased risk for renal and cardiovascular diseases in diabetes. In this pilot study, we determined the effect of weight loss induced by different types of bariatric surgery on albuminuria in severely obese type 2 diabetic (T2DM) subjects.

Methods

Fifteen consecutive T2DM patients (9M/6F, 51 ± 14 years, body mass index (BMI) 49±9 kg/m2, HbA1c 7.2±1.1%) undergoing either Roux-en-Y gastric bypass (RYGB; N=9) or other types of bariatric surgery (N=6) underwent determination of urine albumin/creatinine ratio (UACR) and adipokine and insulin sensitivity during a mixed meal tolerance test performed 2 weeks prior to and 6 months following surgery.

Results

Following RYGB, there was a significant decrease in BMI (−4.74±−5.05 kg/m2), fasting glucose, cholesterol, and leptin levels. Insulin sensitivity (Matsuda index [12.05± 3.81, p=0.003]) and high molecular weight (HMW) adiponectin increased significantly along with a significant reduction in UACR (median, 36 mg/g [7–94] vs. 27 mg/g [5.5–42.5], p=0.01). The reduction in UACR following RYGB was inversely correlated with the Matsuda index (r=−0.74, p=0.02) and HMW adiponectin (r=−0.67, p=0.04). In contrast, despite reduction in BMI (−4.11±−4.10 kg/m2) following other types of bariatric surgery (n=6), there was no significant improvement in insulin sensitivity (0.88±2.40, p=0.63), UACR, or HMW adiponectin levels.

Conclusions

RYGB in severely obese DM subjects is associated with a reduction in albuminuria that correlates to the improvement in insulin sensitivity and HMW adiponectin. The data point to a need for larger studies to confirm these findings and evaluate the micro–macro-vascular benefits including renal parenchymal benefits of different types of bariatric surgery in T2DM.

Visceral fat has been linked to insulin resistance and type 2 diabetes mellitus (T2DM); and emerging data links RBP4 gene expression in adipose tissue with insulin resistance. In this study, we examined RBP4 protein expression in omental adipose tissue obtained from 24 severely obese patients undergoing bariatric surgery, and 10 lean controls (4 males/6 females, BMI = 23.2 ± 1.5 kg/m2) undergoing elective abdominal surgeries. Twelve of the obese patients had T2DM (2 males/10 females, BMI: 44.7 ± 1.5 kg/m2) and 12 had normal glucose tolerance (NGT: 4 males/8 females, BMI: 47.6 ± 1.9 kg/m2). Adipose RBP4, glucose transport protein-4 (GLUT4), and p85 protein expression were determined by western blot. Blood samples from the bariatric patients were analyzed for serum RBP4, total cholesterol, triglycerides, and glucose. Adipose RBP4 protein expression (NGT: 11.0 ± 0.6; T2DM: 11.8 ± 0.7; lean: 8.7 ± 0.8 arbitrary units) was significantly increased in both NGT (P = 0.03) and T2DM (P = 0.005), compared to lean controls. GLUT4 protein was decreased in both NGT (P = 0.02) and T2DM (P = 0.03), and p85 expression was increased in T2DM subjects, compared to NGT (P = 0.03) and lean controls (P = 0.003). Regression analysis showed a strong correlation between adipose RBP4 protein and BMI for all subjects, as well as between adipose RBP4 and fasting glucose levels in T2DM subjects (r = 0.76, P = 0.004). Further, in T2DM, serum RBP4 was correlated with p85 expression (r = 0.68, P = 0.01), and adipose RBP4 protein trended toward an association with p85 protein (r = 0.55, P = 0.06). These data suggest that RBP4 may regulate adiposity, and p85 expression in obese-T2DM, thus providing a link to impaired insulin signaling and diabetes in severely obese patients.

Although nonalcoholic fatty liver disease (NAFLD) is frequent in obesity, the metabolic determinants of advanced liver disease remain unclear. Adipokines reflect inflammation and insulin resistance associated with obesity and may identify advanced NAFLD. At the time of obesity surgery, 142 consecutive patients underwent liver biopsy and had their preoperative demographic and clinical data obtained. Liver histology was scored by the NAFLD activity score, and patients subdivided into four groups. Concentrations of retinol-binding protein 4 (RBP4), adiponectin, tumor necrosis factor-α (TNF-α), and leptin were determined ~1 week prior to surgery and results were related to liver histology. The prevalence of no NAFLD was 30%, simple steatosis 23%, borderline nonalcoholic steatohepatitis (NASH) 28%, and definitive NASH 18%. Type 2 diabetes mellitus (T2DM) and metabolic syndrome (MS) prevalence were 39 and 75%, respectively, and did not differ across the four histological groups (P = NS). Triglyceride (TG) and alanine transaminase (ALT) levels, strongly associated with advanced stages of NAFLD and NASH (P = 0.04). TG levels >150 mg/dl, increased the likelihood of NASH 3.4-fold, whereas high-density lipoprotein (HDL) levels predicted no NAFLD (P < 0.01). Concentrations of TNF-α, leptin, and RBP4 did not differ among histological groups and thus did not identify NASH; however, there was a trend for adiponectin to be lower in NASH vs. no NAFLD (P = 0.061). In summary, both TG and ALT levels assist in identification of NASH in an obesity surgery cohort. These findings underscore the importance of fatty acid delivery mechanisms to NASH development in severely obese individuals.

Background and Objectives:

The objectives of this study were to assess the impact of age following laparoscopic fundoplication (LF).

Methods:

From March 1993 to November 1998, 193 patients underwent LF. Patients comprised 150 young individuals (age<60; median 41) and 43 older individuals (age>60; median 68). Follow-up included heartburn scores, dysphagia scores, and quality of life determined by the Short Form 36 Health Survey (SF36).

Results:

Older patients had more cardiac disease, psychiatric disorders, prior cancers, and upper abdominal operations (P<0.05). DeMeester scores were similar (young 70/older 69). Complications occurred in 13 (8.7%) of the young and 5 (11.6%) of the older patients (P=0.142). No perioperative deaths occurred. Length of stay was longer (P<0.000) in older patients (2.9 versus 1.6 days); resumption of oral intake (young–1.2;older–1.3 days) and return to normal activity (young–3.6;older–4.4 weeks) were similar. Follow-up was available in 102 young (median 17 months) and 35 older (median 18 months) patients. Heartburn and dysphagia scores were excellent in both groups. SF36 scores were similar in both groups. Only 6 (5.9%) of the young group and 1 (2.9%) of the older group were dissatisfied (P=0.652).

Conclusions:

Despite differences in comorbid disease, outcomes were similar in both groups. LF should be considered a therapeutic option in the older patient with reflux.

Background and Objectives:

Lymph node metastases are the most important prognostic factor in patients with esophageal cancer. Histologic examination misses micrometastases in up to 20% of lymph nodes evaluated. In addition, non-invasive imaging modalities are not sensitive enough to detect small lymph nodes metastases. The objective of this study was to investigate the use of reverse transcriptase-polymerase chain reaction (RT-PCR) of messenger RNA (mRNA) for carcinoembryonic antigen (CEA) to increase the detection of micrometastases in lymph nodes from patients with esophageal cancer.

Methods:

RT-PCR of CEA mRNA was performed in lymph nodes from patients with malignant and benign esophageal disease. Each specimen was examined histopathologically and by RT-PCR and the results were compared.

Results:

Metastases were present in 29 of 60 (48%) lymph nodes sample by minimally invasive staging from 13 patients with esophageal cancer when examined histopathologically. RT-PCR identified nodal metastases in 46 of these 60 (77%) samples. RT-PCR detected CEA mRNA in all 29 histologically positive samples and in 17 histologically negative lymph nodes. All lymph nodes from patients with benign disease (n=15) were negative both histopathologically and by RT-PCR. The stage of two patients was reclassified based on the RT-PCR results, which identified lymph node spread undetected histopathologically. Both of these patients developed recurrent disease after resection of the primary tumor.

Conclusions:

RT-PCR is more sensitive than histologic examination in the detection of lymph node metastases in esophageal cancer and can lead to diagnosis of a more advanced stage in some patients. The combination of minimally invasive surgical techniques in combination with new molecular diagnostic techniques may improve our ability to stage cancer patients.

Background:

A number of case reports have described the application of minimally invasive surgical techniques to accomplish esophagectomy. However, most reports have employed thoracoscopic or laparoscopic techniques to perform esophagectomy in addition to an “access” incision which often approaches a standard laparotomy or thoracotomy.

Case Report:

This report describes a total laparoscopic transhiatal esophagectomy in a 55 year old female with Barrett's esophagus and high grade dysplasia.

Conclusions:

The patient had an uneventful recovery and was discharged home on the fourth day after a total laparoscopic esophagectomy. This report demonstrates the technical feasibility of this complex procedure by a minimally invasive approach.

Background:

This study evaluates the feasibility of laparoscopic transfascial suture repair of umbilical hernias when combined with another laparoscopic procedure that potentially contaminates the peritoneal cavity.

Method:

From August 1997 to November 2001, 32 patients underwent laparoscopic umbilical suture repair in association with another laparoscopic procedure. The repair was performed with the Carter-Thomason suture passer.

Results:

Of the 32, 26 patients with more than 1-year follow-up were included in the study. The mean diameter of the umbilical hernia defect was 1.67 cm (range, 0.5 to 3). At a mean follow-up of 34 months (range, 12 to 60), there were only 2 recurrences (7.7%) both of which happened in patients with hernia defects larger than 2 cm in diameter. Apart from 2 wound infections, no other complications occurred.

Conclusion:

Laparoscopic suture repair of umbilical hernias with the suture passer method is effective and durable even when combined with other laparoscopic procedures that potentially contaminate the peritoneal cavity with bile or enteric contents.