- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00360373
Adolescent Gastric By-pass and Diabetic Precursors
January 3, 2014 updated by: Children's Hospital Medical Center, Cincinnati
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati,, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adolescents undergoing weight loss surgery
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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..
|
2 weeks, 3 months, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas H Inge, MD, PhD, Children's Hospital Medical Center, Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jeffreys RM, Hrovat K, Woo JG, Schmidt M, Inge TH, Xanthakos SA. Dietary assessment of adolescents undergoing laparoscopic Roux-en-Y gastric bypass surgery: macro- and micronutrient, fiber, and supplement intake. Surg Obes Relat Dis. 2012 May-Jun;8(3):331-6. doi: 10.1016/j.soard.2011.11.016. Epub 2011 Dec 10.
- Inge TH, Prigeon RL, Elder DA, Jenkins TM, Cohen RM, Xanthakos SA, Benoit SC, Dolan LM, Daniels SR, D'Alessio DA. Insulin Sensitivity and beta-Cell Function Improve after Gastric Bypass in Severely Obese Adolescents. J Pediatr. 2015 Nov;167(5):1042-8.e1. doi: 10.1016/j.jpeds.2015.08.020. Epub 2015 Sep 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
August 2, 2006
First Submitted That Met QC Criteria
August 2, 2006
First Posted (Estimate)
August 4, 2006
Study Record Updates
Last Update Posted (Estimate)
January 6, 2014
Last Update Submitted That Met QC Criteria
January 3, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK68228
- R03DK068228 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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