Microenvironment of Adipose Tissue in Endocannabinoid System

NCT ID: NCT00978289

Last Updated: 2013-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Naji Abumrad

Chairman, Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naji Abumrad, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#080516

Identifier Type: -

Identifier Source: org_study_id

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