Status:
COMPLETED
Adolescent Gastric By-pass and Diabetic Precursors
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
15-45 years
Brief Summary
The purpose of this research study is to find out what effects (good and bad) gastric bypass has on metabolism, including pancreatic insulin secretion. In addition, we will compare the effects of gast...
Detailed Description
Overweight and obesity are the most common metabolic disorders affecting the U.S. with 31% of adults and 16% of adolescents now meeting Centers for Disease Control criteria for these conditions. As th...
Eligibility Criteria
Inclusion
- Approved to be scheduled for laparoscopic gastric bypass surgery for VSO at Cincinnati Children's or University Hospital
- Age at time of gastric bypass surgery date \>15 and \<21 years, or \>30 and \<45 years
- BMI \>40
- Weight at age 18 consistent with severe adolescent obesity (if height \< 5'5" weight \> 200 pounds or if height \>5'5", weight \> 250)
Exclusion
- Diagnosis of cirrhosis, total bilirubin \>1 mg/dL, prothrombin time \> 13.3 sec
- Prior myocardial infarction
- Serum creatinine \>1.7mg/dL
- Systemic (PO, IV, IM) glucocorticoid therapy within the previous six weeks prior to blood sampling
- Peri-menopausal (irregularity of menstrual periods over the past 3 months (67) or demonstrated abnormally high follicle stimulating hormone levels (68)
- Severe T2DM (on insulin for control of hyperglycemia, or HbA1c \> 8.5)
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00360373
Start Date
August 1 2005
End Date
February 1 2012
Last Update
January 6 2014
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229