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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by East Carolina University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
East Carolina University
ClinicalTrials.gov Identifier:
NCT00887302
First received: April 22, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


Condition
Type II Diabetes Mellitus
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Johnson and Johnson Ethicon Metabolics of RYGB With Gastrostomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by East Carolina University:

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 Not yet recruiting
Greenville, North Carolina, United States, 2783
Contact: Kelly E Jernigan, BS Biology     252-744-3361     jernigank@ecu.edu    
Contact: Rita Bowden, RN     252-744-3361     bowdenr@ecu.edu    
Sponsors and Collaborators
East Carolina University
Johnson & Johnson
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on May 16, 2013