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

April 22, 2009
April 22, 2009
May 2009
June 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Non-Probability Sample

Obese caucasian females between the ages of 18-60 who have had bariatric surgery.

  • Type II Diabetes Mellitus
  • Obesity
Not Provided
  • 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.
 
Not yet recruiting
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
Female
18 Years to 60 Years
No
United States
 
NCT00887302
J&J Ethicon
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP