Overview

This trial is active, not recruiting.

Conditions surgical condition before and after gastric bypass surgery, diet condition: before and after a weight loss equivalent to what patients lose 1 month after gbp 9approximately 10kg)
Treatments gastric bypass surgery, diet induced weight loss
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date September 2005
End date December 2010
Trial size 20 participants
Trial identifier NCT00571220, DK67561 (completed)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
gastric bypass surgery
weight loss bariatric surgery
Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age.
diet induced weight loss
low calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Eligibility Criteria

Male or female participants from 21 years up to 60 years old.

Inclusion Criteria: - morbidly obese with type 2 diabetes candidates and being evaluated at our instituion for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lsoe weight by diet. Exclusion Criteria: - any condition that would be contra-indicated for bariatric surgery (ex:unstable angina) - diabetes treated by insulin, TZD, exenatide, DPP-IV inhibitors - HbA1C > 8%

Additional Information

Official title Mechanisms of Diabetes Control After Weight Loss Surgery
Principal investigator Blandine Laferrere, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).