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

January 26, 2011
January 26, 2011
September 2010
February 2014   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function
Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function

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.

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.

Interventional
Not Provided
Intervention Model: Crossover Assignment
Masking: Open Label
Severely Obese Patients
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.
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
Intervention: Procedure: bariatric surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Anne Dutour, Professor +33491968639 anne.dutour@ap-hm.fr
France
 
NCT01284816
2010-A00696-33
No
Assistance Publique des Hôpitaux de Marseille, Direction de la Recherche
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Anne Dutour, Professor AP-HM
Assistance Publique Hopitaux De Marseille
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP