Adolescent Gastric By-pass and Diabetic Precursors

Completed

Conditions studied: Obesity

In brief

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 gastric bypass on the metabolism of adults and adolescents to try to determine whether there are greater metabolic and health advantages of performing gastric bypass earlier in life versus waiting until adulthood.

Key facts

Study ID

NCT00360373

Run by

Children's Hospital Medical Center, Cincinnati

People needed

30

Starts

2005-08-01

Expected to finish

2012-02-01

Last updated by the study team

2014-01-06

Who can join

Age: 15 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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