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Metabolics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy (J&J Ethicon)
This study is not yet open for participant recruitment.
Verified by East Carolina University, April 2009
First Received: April 22, 2009   No Changes Posted
Sponsors and Collaborators: East Carolina University
Johnson & Johnson
Information provided by: East Carolina University
ClinicalTrials.gov Identifier: NCT00887302
  Purpose

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


Condition
Type II Diabetes Mellitus
Obesity

MedlinePlus related topics: Diabetes Obesity
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort
Official Title: Johnson and Johnson Ethicon Metabolics of RYGB With Gastrostomy

Further study details as provided by East Carolina University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Estimated Enrollment: 120
Study Start Date: May 2009
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Gastric Band
2
Gastric Sleeve
3
Gastric Bypass with PEG 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887302

Locations
United States, North Carolina
East Carolina University Brody School of Medicine
Greenville, North Carolina, United States, 2783
Sponsors and Collaborators
East Carolina University
Johnson & Johnson
  More Information

No publications provided

Responsible Party: East Carolina University ( Dr. Walter J. Pories, M.D., FACS, Professor of Surgery, Biochemistry, Exercise and Sports Science )
Study ID Numbers: J&J Ethicon
Study First Received: April 22, 2009
Last Updated: April 22, 2009
ClinicalTrials.gov Identifier: NCT00887302     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Nutrition Disorders
Endocrine System Diseases
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009