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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
Health authority
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%

Study Design


Related Conditions & MeSH terms


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
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