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

Obesity Clinical Trial

Official title:

Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887302
• Other study ID #: J&J Ethicon
• Status: Completed
• Start date: March 25, 2009
• Est. completion date: October 12, 2012

Study information

• Verified date: October 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 12, 2012
• Est. primary completion date: October 12, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type II Diabetes Mellitus

Intervention

Procedure:
• Gastric Band
Places a band over the upper portion of the stomach.
• Gastric Sleeve
Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach
• Gastrostomy Tube
Tube is inserted into the stomach that delivers nutrition directly into the stomach.

Locations

Country	Name	City	State
United States	East Carolina University Brody School of Medicine	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
East Carolina University	Johnson & Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolics of RYGB with Gastrostomy - Insulin	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	03/25/2009-10/12/2012
Primary	Metabolics of RYGB with Gastrostomy - Glucose	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	03/25/2009-10/12/2012