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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by East Carolina University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00887302
First Posted: April 23, 2009
Last Update Posted: April 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson
Information provided by:
East Carolina University
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 22, 2009
First Posted: April 23, 2009
Last Update Posted: April 23, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases