Microenvironment of Adipose Tissue in Endocannabinoid System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00978289
First received: September 15, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microenvironment of Adipose Tissue in Endocannabinoid System Before and After Roux-en-y Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Biospecimen Retention:   Samples With DNA

Whole blood, adipose tissue, adipose tissue microdialysate


Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Naji Abumrad, Chairman, Department of Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00978289     History of Changes
Other Study ID Numbers: IRB#080516
Study First Received: September 15, 2009
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
obesity
gastric bypass surgery

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Endocannabinoids
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014