Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function

July 23, 2015 updated by: Assistance Publique Hopitaux De Marseille

Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown.

The researchers thus investigated the effect of bariatric surgery on EAT in severely obese patients. The primary endpoint of this study was the change in EAT amount 6 months after bariatric surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The best of our knowledge, no study has really addressed whether this EAT was modulated by diet or therapeutics like bariatric surgery. The researchers were particularly interested in studying the impact of bariatric surgery and of weight loss on the amount of EAT and whether reduction in EAT could have a positive impact on myocardial function.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13
        • AP-HM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men or women who have more than 18 years
  • patients have been informed and have consented
  • severely obese patients with surgery indication

Exclusion Criteria:

  • contraindications at surgery, at MNR imagery
  • History of infarct, of congenital cardiomyopathy
  • Treatment modifying the distribution of the fat
  • Pregnant or breast-feeding women
  • patients less than 18 years
  • Patient without consentment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: severely obese patients
35 patients addressed for severe obesity in the Endocrinology department of Marseille North Hospital before (V1) and 6 months (V2) after bariatric surgery
Procedure: bariatric surgery
The bariatric surgery is a relevant treatment for severely obese patients those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in EAT amount 6 months after bariatric surgery.
Time Frame: 36 months
We thus investigated the effect of bariatric surgery on EAT in severely obese patients.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of 3 parameters
Time Frame: 36 months
  1. to evaluate the variation in myocardial, hepatic , pancreatic and triglyceride content
  2. to evaluate the variation in left ventricular function or myocardial function
  3. and to describe the relationships between changes in visceral abdominal fat, subcutaneous fat and epicardial fat
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Anne Dutour, Professor, AP-HM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 23, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-A00696-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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