Status:
COMPLETED
Relationship Between Changes in Gut Hormones After Gastric Bypass and Gastric Banding and Improvements in Diabetes
Lead Sponsor:
University of Pennsylvania
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
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 h...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01153438
Start Date
April 1 2011
End Date
June 1 2013
Last Update
August 17 2016
Active Locations (1)
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1
Center for Weight and Eating Disorders, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104