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

This study is currently recruiting participants.
Verified January 2011 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01284816
First received: January 26, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Severely Obese Patients
 Procedure: bariatric surgery

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • The change in EAT amount 6 months after bariatric surgery. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    We thus investigated the effect of bariatric surgery on EAT in severely obese patients.


Secondary Outcome Measures:
  • Evaluation of 3 parameters [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    1. to evaluate the variation in myocardial 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


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
severely obese patients
20 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284816

Contacts
Contact: Anne Dutour, Professor +33491968639 anne.dutour@ap-hm.fr

Locations
France
AP-HM Recruiting
Marseille, France, 13
Contact: Anne Dutour, Professor     +33491968639     anne.dutour@ap-hm.fr    
Principal Investigator: Anne Dutour, Professor            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Anne Dutour, Professor AP-HM
  More Information

No publications provided

Responsible Party: Assistance Publique des Hôpitaux de Marseille, Direction de la Recherche
ClinicalTrials.gov Identifier: NCT01284816     History of Changes
Other Study ID Numbers: 2010-A00696-33
Study First Received: January 26, 2011
Last Updated: January 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
severely obese patients

ClinicalTrials.gov processed this record on May 19, 2013