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

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ClinicalTrials.gov Identifier: NCT00887302
Recruitment Status : Unknown
Verified April 2009 by East Carolina University.
Recruitment status was:  Not yet recruiting
First Posted : April 23, 2009
Last Update Posted : April 23, 2009
Sponsor:
Collaborator:
Information provided by:

April 22, 2009
April 23, 2009
April 23, 2009
May 2009
June 2010   (Final data collection date for primary outcome measure)
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No Changes Posted
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Metabolics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
Johnson and Johnson Ethicon Metabolics of RYGB With Gastrostomy
This study is an investigation of the "metabolics of RYGB with gastrostomy."

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.

Observational
Observational Model: Cohort
Not Provided
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Non-Probability Sample
Obese caucasian females between the ages of 18-60 who have had bariatric surgery.
  • Type II Diabetes Mellitus
  • Obesity
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  • 1
    Gastric Band
  • 2
    Gastric Sleeve
  • 3
    Gastric Bypass with PEG tube
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
Not Provided
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00887302
J&J Ethicon
No
Not Provided
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Dr. Walter J. Pories, M.D., FACS, Professor of Surgery, Biochemistry, Exercise and Sports Science, East Carolina University
East Carolina University
Johnson & Johnson
Not Provided
East Carolina University
April 2009