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

Tracking Information
First Received Date ^ICMJE	April 22, 2009
Last Updated Date	April 22, 2009
Start Date ^ICMJE	May 2009
Estimated Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Metabolics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
Official Title ^ICMJE	Johnson and Johnson Ethicon Metabolics of RYGB With Gastrostomy
Brief Summary	This study is an investigation of the "metabolics of RYGB with gastrostomy."
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 ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Obese caucasian females between the ages of 18-60 who have had bariatric surgery.
Condition ^ICMJE	Type II Diabetes Mellitus Obesity
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Gastric Band 2 Gastric Sleeve 3 Gastric Bypass with PEG tube
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	120
Completion Date	Not Provided
Estimated Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00887302
Other Study ID Numbers ^ICMJE	J&J Ethicon
Has Data Monitoring Committee	No
Responsible Party	Dr. Walter J. Pories, M.D., FACS, Professor of Surgery, Biochemistry, Exercise and Sports Science, East Carolina University
Study Sponsor ^ICMJE	East Carolina University
Collaborators ^ICMJE	Johnson & Johnson
Investigators ^ICMJE	Not Provided
Information Provided By	East Carolina University
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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