Adolescent Gastric By-pass and Diabetic Precursors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00360373
First received: August 2, 2006
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adolescent Gastric By-pass and Diabetic Precursors

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Insulin Resistance [ Time Frame: 2 weeks, 3 months, and 12 months ] [ Designated as safety issue: No ]
    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..


Enrollment: 30
Study Start Date: August 2005
Study Completion Date: February 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adolescents undergoing weight loss surgery

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00360373

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati,, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Thomas H Inge, MD, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00360373     History of Changes
Other Study ID Numbers: DK68228, R03DK068228
Study First Received: August 2, 2006
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Medical Center, Cincinnati:
bariatric
obesity
insulin resistance
gastric bypass
adolescent

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014