ObesityNCT00978289
Microenvironment of Adipose Tissue in Endocannabinoid System
An observational study of Obesity, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects approved and scheduled for gastric bypass surgery
Who may be able to join
- BMI>35 kg/m2
- Age 20-60 yrs
- Approved and scheduled for gastric bypass surgery
- Stable body weight for past 3 months
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Microenvironment of Adipose Tissue in Endocannabinoid System Before and After Roux-en-y Gastric Bypass Surgery
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.
- Conditions
- Obesity
- Keywords
- obesity, gastric bypass surgery
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Abumrad, Vanderbilt University
- Investigators
- Naji Abumrad, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978289
- Sponsor's protocol ID
- IRB#080516
- Status last verified
- Jun 2013
- First submitted
- 15 Sep 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microenvironment of Adipose Tissue in Endocannabinoid System Before and After Roux-en-y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT00978289
- Acronym / sponsor ID
- IRB#080516
- Conditions
- Obesity
- Keywords
- obesity, gastric bypass surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects approved and scheduled for gastric bypass surgery
Key inclusion criteria (4 listed)
- BMI>35 kg/m2
- Age 20-60 yrs
- Approved and scheduled for gastric bypass surgery
- Stable body weight for past 3 months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naji Abumrad, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.