Mechanisms of Diabetes Relapse After Bariatric Surgery
The purpose of this study is to understand the mechanisms of type 2 diabetes remission and relapse after Gastric Bypass Surgery (GBP). The investigators will be studying the effect of glucose and hormones on the production of insulin.
The investigators expect to find that individuals who have a relapse of diabetes after GBP have a weaker insulin secretion response to various stimuli. Subjects with Diabetes relapse will also be less sensitive to insulin, and will have more body fat.
Type 2 Diabetes
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Mechanisms of Diabetes Relapse After Bariatric Surgery|
- Difference in insulin secretion between groups. [ Time Frame: 2-8 Weeks ] [ Designated as safety issue: No ]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: 2-8 ] [ Designated as safety issue: No ]The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.
- Difference in Body composition between groups [ Time Frame: 2-8 Weeks ] [ Designated as safety issue: No ]The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.
Biospecimen Retention: Samples With DNA
Serum, Pellet, Urine, Stool, Saliva
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Diabetes Relapse after GBP
Participants who are at least 1 year post GBP surgery, AND had documented Type 2 Diabetes before surgery AND currently have Type 2 Diabetes as per American Diabetes Association diagnostic criteria.
Diabetes Remission after GBP
Participants who are at least 1 year post GBP surgery, AND who had documented Type 2 Diabetes prior to surgery AND currently have normal glucose tolerance as per American Diabetes Association criteria.
Weight Matched Non-Operated Controls
Participants who have never had any kind of bariatric surgery, are overweight to moderately obese, and have no personal or family history of Type 1, Type 2, or Gestational Diabetes.
The purpose of this study is to understand the mechanisms of type 2 diabetes remission and relapse after Gastric Bypass Surgery (GBP).
In this cross sectional study, three groups will be studied:
- Patients who have undergone GBP at least 1 year ago, had documented type 2 diabetes prior to GBP and currently have persistent or relapsed diabetes.
- Patients who have undergone GBP at least 1 year ago, had documented type 2 diabetes prior to GBP and are currently in full diabetes remission.
- Overweight or moderately obese patients without any diabetes, who have not undergone bariatric surgery.
At the New York Obesity Research Center of St. Luke's Roosevelt Hospital Center in New York City, The investigators will study approximately 12-15 patients from each of these groups for a total of approximately 40 patients.
Patients will have four appointments each, which will take place over the course of approximately 2 to 8 weeks. Over the four visits the investigators will assess insulin secretion in response to oral and various intravenous nutrient or hormonal stimuli. Body composition will be assessed to look at fat mass and distribution.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516320
|Contact: Blandine Laferrere, MDfirstname.lastname@example.org|
|United States, New York|
|New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center||Not yet recruiting|
|New York, New York, United States, 10025|
|Principal Investigator: Blandine Laferrere, MD|
|Principal Investigator:||Blandine Laferrere, MD||New York Obesity Nutrition Research Center|