Clinical Trials Directory

Trials / Completed

CompletedNCT00571220

Mechanisms of Diabetes Control After Weight Loss Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Sex
All
Age
21 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREgastric bypass surgeryweight loss bariatric surgery
OTHERDiet induced weight losslow calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Timeline

Start date
2005-09-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2007-12-11
Last updated
2018-03-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00571220. Inclusion in this directory is not an endorsement.