Relationship Between Changes in Gut Hormones After Gastric Bypass and Gastric Banding and Improvements in Diabetes

Completed

Conditions studied: Type 2 Diabetes, Obesity, Bariatric Surgery

In brief

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).

Key facts

Study ID

NCT01153438

Run by

University of Pennsylvania

People needed

8

Starts

2011-04-01

Expected to finish

2013-06-01

Last updated by the study team

2016-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants age 18 years or older with a body mass index greater than >35 kg/m2 but less than <60 kg/m2 who undergo gastric bypass or gastric banding at the University of Pennsylvania.
• Type 2 diabetes (defined as a pre-existing diagnosis, the use of oral antidiabetic medications or insulin, or a fasting plasma glucose greater than or equal to > 126 mg/dl and confirmed by a oral glucose tolerance test)
• Ability to provide written informed consent

You may not qualify if…

• A diagnosis of type 1 diabetes
• Daily insulin requirement exceeding 1 unit/kg/d
• Poor preoperative glycemic control, as indicated by an HbA1c greater than 10.0%
• Duration of diabetes greater than> 10 years
• Pregnant women (or those who intend to become pregnant during the study period)
• Women who are currently breastfeeding
• Participants with moderate anemia (hemoglobin less than< 12 g/dl for men and less than< 11 g/dl for women)
• Use of medications known to affect weight, including chronic oral or inhaled glucocorticoid use and the use of certain psychiatric medications (olanzepine, risperidone, and lithium)
• history of any major active rheumatologic, pulmonary, dermatologic disease, or inflammatory conditions
• oral history of positive HIV status
• any major surgery in the past 3 months
• regular use of alcoholic beverages (greater than 7 drinks/week)
• prior reaction to human albumin

Where it is running

• Center for Weight and Eating Disorders, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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