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

Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy

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

Study Overview

• Status: Completed
• Conditions: Obesity; Type II Diabetes Mellitus
• Intervention / Treatment: Procedure: Gastric Band; Procedure: Gastric Sleeve; Procedure: Gastrostomy Tube

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University Brody School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Obese caucasian females between the ages of 18-60 who have had bariatric surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Restricted food intake without rerouting food flow cohort; Obese non-diabetic patients and diabetic patients undergoing gastric band surgery will be studied before they have surgery, 1 week after the band is adjusted to restrict food intake and again after they have lost the weight equal to that which gastric bypass patients loose 3 months after surgery (to match data we already have in the current study). All patients will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and IV glucose-induced insulin secretion and a meal challenge to measure the secretion of metabolites and peptides.	Procedure: Gastric Band; Places a band over the upper portion of the stomach.
Response to meal when a portion of the stomach is excluded from food flow cohort; Obese-diabetic patient undergoing gastric sleeve surgery will be studied before they have surgery, 1 week after surgery and again 3-6 months after surgery (to match data we already have in the current study). The patient will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and insulin secretion and a meal challenge to measure the secretion of metabolites and peptides.	Procedure: Gastric Sleeve; Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach
Response to meal when a portion of the GI tract is excluded from food flow cohort; In approximately 6 patients/year our surgeons have to insert a gastrostomy tube into the bypassed stomach of gastric bypass patients. This provides a unique opportunity to see the changes in metabolites and peptides in blood in response to a meal delivered to the bypassed stomach, duodenum and proximal jejunum. Since we can not anticipate which patients will require this procedure, we cannot do tests before surgery, but we will do four tests post-operatively: (1) an IV glucose tolerance test, (2) an oral meal challenge (with Hi-cal), and (3) a meal challenge (identical to that given orally/Hi-Cal) delivered through the gastrostomy tube. Gastrostomy subjects will also have a 4) test, a 75 gram dextrose meal challenge.	Procedure: Gastrostomy Tube; Tube is inserted into the stomach that delivers nutrition directly into the stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: East Carolina University
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: Walter Pories, MD, East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2009
• Primary Completion (Actual): October 12, 2012
• Study Completion (Actual): October 12, 2012

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimated): April 23, 2009

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: J&J Ethicon