Clinical trial NCT00571220: Mechanisms of Diabetes Control After Weight Loss Surgery
Official title: Mechanisms of Diabetes Control After Weight Loss Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Bypass Surgery
Obesity
Keywords: gastric bypass
diabetes
obesity
diet-induced weight loss
incretin levels (GLP-1,GIP)
incretin effect
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbidly obese patients with type 2 diabetes of less than 5 years duration

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.


Eligibility criteria: 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%

Primary outcomes:
measure: Change in incretin
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St Luke's Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Blandine Laferrere, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laferrere 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. doi: 10.2337/dc06-1549. Epub 2007 Apr 6.
citation: Dutia R, Brakoniecki K, Bunker P, Paultre F, Homel P, Carpentier AC, McGinty J, Laferrere B. Limited recovery of beta-cell function after gastric bypass despite clinical diabetes remission. Diabetes. 2014 Apr;63(4):1214-23. doi: 10.2337/db13-1176. Epub 2013 Dec 2.
citation: Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25.