Mechanisms of Diabetes Control After Weight Loss Surgery

Obesity Clinical Trial

Official title:

Mechanisms of Diabetes Control After Weight Loss Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571220
• Other study ID #: DK67561 (completed)
• Secondary ID: R01DK067561
• Status: Completed
• Phase: N/A
• First received: December 7, 2007
• Last updated: March 7, 2018
• Start date: September 2005
• Est. completion date: December 2010

Study information

• Verified date: March 2018
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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%

Related Conditions & MeSH terms

• Gastric Bypass Surgery
• Obesity
• Weight Loss

Intervention

Procedure:
• gastric bypass surgery
weight loss bariatric surgery

Other:
• Diet induced weight loss
low calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Locations

Country	Name	City	State
United States	St Luke's Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Laferrère B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, Hart AB, Olivan B. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1709-16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in incretin	Change in incretin (gastric inhibitory peptide [GIP] and glucagon-like peptide-1 [GLP-1])	One month