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Microenvironment of Adipose Tissue in Endocannabinoid System

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ClinicalTrials.gov Identifier: NCT00978289
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University

Brief Summary:
The purpose of this study is examine the relationship between adipose tissue inflammation and activation of the endocannabinoid system before and after Roux-en-Y gastric bypass surgery. The investigators hypothesize that the metabolic improvements and weight loss are due to mechanisms that antagonize the endocannabinoid system.

Condition or disease
Obesity

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microenvironment of Adipose Tissue in Endocannabinoid System Before and After Roux-en-y Gastric Bypass Surgery
Study Start Date : July 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012



Biospecimen Retention:   Samples With DNA
Whole blood, adipose tissue, adipose tissue microdialysate


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects approved and scheduled for gastric bypass surgery
Criteria

Inclusion Criteria:

  • BMI>35 kg/m2
  • Age 20-60 yrs
  • Approved and scheduled for gastric bypass surgery
  • Stable body weight for past 3 months

Exclusion Criteria:

  • Positive pregnancy test
  • Previous gastric surgeries
  • Intercurrent infections
  • History of ketoacidosis or current metabolic acidosis
  • Serum creatinine or liver function tests > 2 times upper limits of normal
  • Taking drugs that are known to affect carbohydrate or lipid metabolism other than anti-diabetes mediations.

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): NCT00978289


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Naji Abumrad, MD Vanderbilt University Medical Center

Responsible Party: Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00978289     History of Changes
Other Study ID Numbers: IRB#080516
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Naji Abumrad, Vanderbilt University:
obesity
gastric bypass surgery