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Adolescent Gastric By-pass and Diabetic Precursors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360373
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : January 6, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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 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.

Condition or disease

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 the obesity epidemic has unfolded, so too has the increase in prevalence of abnormalities of carbohydrate metabolism. The single most effective treatment for type 2 diabetes in severely obese adults may be bariatric surgery, a procedure that is most commonly performed in the 5th and 6th decades of life. While it is clear that rapid and profound weight loss can significantly improve carbohydrate metabolism in adults, it is not clear to what degree type 2 diabetes is reversible in these patients. The pathophysiology of type 2 diabetes in adolescents and children is not well understood and no studies have yet examined the effect of surgical weight loss on insulin resistance, insulin secretion, or glucose tolerance in severely obese young people. However, it seems likely that bariatric surgery could improve these conditions in youth. Understanding the relative benefits of surgically induced weight reduction on carbohydrate metabolism in adolescents compared to older subjects is important for determining optimal timing of this intervention. This knowledge may also lead to key insights into obesity-induced diabetes. In this project we will test the hypothesis that bariatric surgical intervention will more effectively improve insulin resistance, β cell dysfunction, and glucose tolerance in adolescents compared to adults. Three specific aims are proposed: 1) To compare the derangements of carbohydrate metabolism among very severely obese (body mass index ≥ 40 kg/m2) adolescents and adults referred for bariatric surgery; 2) To assess improvement in carbohydrate metabolism longitudinally (during and after surgical weight loss) comparing differences in the mechanisms of improvement between the two age groups; 3) To compare major complications in the two age groups following bariatric surgery. These data will provide critical information about age-related metabolic outcomes of bariatric surgery and could inform the design of larger studies to examine the role of early bariatric surgery in management of disorders related to insulin resistance in patients at high risk for these conditions.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adolescent Gastric By-pass and Diabetic Precursors
Study Start Date : August 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : February 2012

Primary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 2 weeks, 3 months, and 12 months ]
    This study uses the frequently sampled intravenous glucose tolerance test (FSIVGTT) to determine the effects of bariatric surgery on insulin resistance, carbohydrate metabolism, β cell dysfunction, and glucose tolerance for this adolescent cohort. Carbohydrate metabolism will be assessed by measuring plasma glucose and insulin concentrations in blood samples obtained during fasting as well as during FSIVGTT at baseline and all subsequent time points..

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescents undergoing weight loss surgery

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00360373

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati,, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Thomas H Inge, MD, PhD Children's Hospital Medical Center, Cincinnati

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT00360373    
Other Study ID Numbers: DK68228
R03DK068228 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Keywords provided by Children's Hospital Medical Center, Cincinnati:
insulin resistance
gastric bypass
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms