Mechanisms of Diabetes Relapse After Bariatric Surgery (LAF26)
|ClinicalTrials.gov Identifier: NCT01516320|
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Procedure: Roux-en-Y Gastric Bypass Procedure: Laparoscopic adjustable gastric banding Procedure: Vertical Sleeve Gastrectomy||Not Applicable|
The mechanisms of type 2 diabetes (T2DM) remission after gastric bypass surgery (GBP) are unclear. The levels of the gut hormones incretins and their effect on insulin secretion, which is impaired in T2DM, markedly increase after GBP. The anatomical changes of GBP, rather than weight loss, seem to be responsible for the changes of incretins. The objective of this proposal is to investigate the different mechanisms by which GBP, laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly patients with T2DM after GBP, LAGB or VSG.
AIM 1: Will study the short term changes of incretins levels and effect in obese individuals with T2DM after GBP, LAGB or VSG, before and 1 month after GBP or before and after equivalent weight loss after LAGB or VSG.
AIM 2: Will study the long-term (12 and 24 months after surgery) changes in the incretin effect on insulin secretion, in patients with T2DM after GBP, LAGB or VSG.
AIM 3: Will study the changes of insulin secretion to IV glucose (AIRg) and insulin sensitivity (Si), measured by the minimal model, in patients with T2DM after GBP, VSG or LAGB, before and at 24 months after the surgery, at weight stability under condition of controlled diet.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Mechanisms of Diabetes Relapse After Bariatric Surgery|
|Actual Study Start Date :||May 13, 2009|
|Actual Primary Completion Date :||September 1, 2014|
|Actual Study Completion Date :||September 1, 2014|
Experimental: Gastric Bypass (GBP) Subjects
Subjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.
Procedure: Roux-en-Y Gastric Bypass
A surgical technique in which the stomach is stapled into a smaller pouch and then attached directly to the small intestine, bypassing the rest of the original stomach. The goal of the surgery is weight loss.
Active Comparator: Laparoscopic adjustable gastric banding (LAGB) Subjects
Subjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity.
Procedure: Laparoscopic adjustable gastric banding
A surgical technique in which an inflatable silicone device placed around the top portion of the stomach, creating a smaller gastric pouch. The goal of the surgery is weight loss.
Active Comparator: Vertical Sleeve Gastrectomy (VSG) Subjects
Subjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.
Procedure: Vertical Sleeve Gastrectomy
A surgical technique in which a large portion of the stomach is removed, leaving only a smaller gastric pouch. The goal of the surgery is weight loss.
- Difference in insulin secretion between groups. [ Time Frame: 0 - 48 months after surgery ]The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.
- Difference in Incretin hormone response between groups. [ Time Frame: 0 - 48 months after surgery ]The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.
- Difference in Body composition between groups [ Time Frame: 0 - 48 months after surgery ]The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516320
|United States, New York|
|New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10025|
|Principal Investigator:||Blandine Laferrere, MD||New York Obesity Nutrition Research Center|