Mechanisms of Diabetes Control After Weight Loss Surgery

Completed

• Conditions: Gastric Bypass Surgery; Obesity
• Interventions: Other: Diet induced weight loss; Procedure: gastric bypass surgery

• Registration Number: NCT00571220
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.

Exclusion Criteria

• any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)
• diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors
• HbA1C > 8%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diet induced weight loss	Diet induced weight loss	Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age.
Gastric bypass surgery	gastric bypass surgery	Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery

Primary Outcome Measures

Name	Time	Method
Change in incretin	One month	Change in incretin (gastric inhibitory peptide \[GIP\] and glucagon-like peptide-1 \[GLP-1\])

Trial Locations

Locations (1)

St Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States