Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy

Completed

• Conditions: Obesity; Type II Diabetes Mellitus

• Registration Number: NCT00887302
• Lead Sponsor: East Carolina University

Brief Summary

This study is an investigation of the "metabolomics of RYGB with gastrostomy."

Detailed Description

The rapid and durable remission of type II diabetes mellitis following the gastric bypass operation challenges the current concepts about the etiology of the disease. The surgery, which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly obese individuals who undergo the operation return to a long-term euglycemia with a prolongation of life and a reduction of health care costs.

The investigators at East Carolina University and those at Johnson and Johnson propose to further complete the profile of the upper gut by extending their observation to three additional human models. The investigators will study patients having the gastric band procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG tube inserted later.

Study Timeline

• Study Start: 2009-03-25
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2012-10-12
• Study Completion: 2012-10-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• Female
• 18-60 years of age
• BMI of 35-65
• Willing to comply with study requirements and long term follow-up
• Capable of understanding the requirements and consequences of surgery and the study
• Is scheduled to have bariatric surgery performed
• Has a negative pregnancy test

Exclusion Criteria

• Repeat gastric bypass procedure
• Patients who are unable to hold their insulin coverage for 48 hours prior to research visits
• Patients taking TZDs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolics of RYGB with Gastrostomy - Insulin	03/25/2009-10/12/2012	The patient will be weighed after voiding. The weight will then be used to determine the amount of insulin to be administered during the minimal model. The following formulas will be used to calculate the insulin dosages: REGULAR INSULIN: body mass (kg) X 0.025 U
Metabolics of RYGB with Gastrostomy - Glucose	03/25/2009-10/12/2012	The patient will be weighed after voiding. The weight will then be used to determine the amount of glucose to be administered during the minimal model. The following formulas will be used to calculate the glucose dosages: GLUCOSE: mls of 50% solution of glucose= body mass (kg) X 0.3g X 2

Trial Locations

Locations (1)

East Carolina University Brody School of Medicine; 🇺🇸 Greenville, North Carolina, United States