NCT00360373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

3.6 years

First QC Date

August 2, 2006

Last Update Submit

January 3, 2014

Conditions

Obesity

Keywords

bariatricobesityinsulin resistancegastric bypassadolescent

Outcome Measures

Primary Outcomes (1)

  • Insulin Resistance

    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

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents undergoing weight loss surgery

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

  • 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.

    PMID: 22260884RESULT

  • 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.

    PMID: 26363548DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Thomas H Inge, MD, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2006

First Posted

August 4, 2006

Study Start

August 1, 2005

Primary Completion

March 1, 2009

Study Completion

February 1, 2012

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

US(1)