NCT00978289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4.4 years

First QC Date

September 15, 2009

Last Update Submit

June 17, 2013

Conditions

Obesity

Keywords

obesitygastric bypass surgery

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects approved and scheduled for gastric bypass surgery

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, adipose tissue, adipose tissue microdialysate

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Naji Abumrad, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Department of Surgery

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)