Relationship Between Changes in Gut Hormones After Gastric Bypass and Gastric Banding and Improvements in Diabetes
Recruitment status was Recruiting
The purpose of this study is to see how hormones that control blood sugar change in response to two different weight loss surgeries (gastric bypass and gastric banding). We believe that changes in a hormone called glucagon-like peptide-1 (GLP-1) may account for the greater improvement in blood sugar after certain types of surgeries. GLP-1 makes the pancreas release insulin, a hormone that lowers blood sugar. The study will consist of one screening visit and three study visits in which the glucose response will be measured after drinking a liquid meal: 1) Visit 1 (2-3 weeks before surgery); 2) Visit 2 (after 10% of body weight is lost); and 3) Visit 3 (5-10 days after Visit 2). Hormone levels will be measured during the three study visits. To see if the improvement in blood sugar after surgery is due to changes in GLP-1, we will block its effect on insulin release by giving either salt water or a medication that blocks the activity of GLP-1 during the two visits that take place after surgery (Visits 2 and 3).
|Study Design:||Time Perspective: Prospective|
|Official Title:||Role of Endogenous Glucagon-like Peptide-1 (GLP-1) in Improved Glucose Tolerance After Two Different Types of Bariatric Surgery|
- change in glucose tolerance after surgery (measured by glucose area under the curve) [ Time Frame: after surgery when 10% of initial body weight is lost (expected 4 weeks after bypass and 12 weeks after banding) ] [ Designated as safety issue: No ]To compare change in glucose tolerance, independent of weight loss, between obese, diabetic participants who undergo gastric bypass or gastric banding.
- change in glucose tolerance before and after a GLP-1 receptor blocker is administered [ Time Frame: after 10% of body weight is lost (expected 4 weeks after bypass and 12 weeks after banding) ] [ Designated as safety issue: No ]To determine if GLP-1 is responsible for improved glucose tolerance following gastric bypass.
Biospecimen Retention: Samples Without DNA
Extra blood will be stored for the potential analysis of additional hormones.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Gastric bypass, Gastric banding|
Many diabetic patients who have Roux-en-Y gastric bypass (RYGB) have rapid improvements in their blood sugars within days of their surgery, even before they have lost much weight. It typically takes much longer for these improvements to occur after adjustable gastric banding (AGB), despite an equally low caloric intake. Changes in levels of hormones released by the small intestine as a consequence of the particular type of surgery may be an important factor in the rapid improvement of blood sugars. One of these hormones, glucagon-like peptide-1 (GLP-1), has an important effect on insulin secretion from the pancreas. This study seeks to determine whether changes in GLP-1 are responsible for the improvement in blood sugar after certain types of weight loss surgeries. In order to meet inclusion criteria, participants must have type 2 diabetes for less than 10 years and be approved by insurance to undergo RYGB or AGB at the Hospital of the University of Pennsylvania or Penn Presbyterian Medical Center. We will obtain several measurements of GLP-1 and other hormones that affect glucose levels during the three study visits: 1) Visit 1 (2-3 weeks before surgery); 2) Visit 2 (after 10% of body weight is lost); and 3) Visit 3 (5-10 days after Visit 2). To see if the improvement in blood sugar after surgery is due to changes in GLP-1, we will block its effect on insulin release by giving either salt water or a medication that blocks the activity of GLP-1 during the two visits that take place after surgery (Visits 2 and 3). Each visit will last for 4-6 hours and participants will be compensated for their time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153438
|Contact: Marion L Vetter, MD, RD||215-746-5129||Marion.Vetter@uphs.upenn.edu|
|United States, Pennsylvania|
|Center for Weight and Eating Disorders, University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Marion Vetter, MD, RD 215-746-5129 firstname.lastname@example.org|
|Contact: Scott Ritter, MS 215-746-3818 email@example.com|
|Principal Investigator: Marion L Vetter, MD, RD|
|Principal Investigator:||Marion L Vetter, MD, RD||University of Pennsylvania|