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

Not Applicable

Completed

• Conditions: Severely Obese Patients
• Interventions: Procedure: bariatric surgery

• Registration Number: NCT01284816
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
severely obese patients	bariatric surgery	35 patients addressed for severe obesity in the Endocrinology department of Marseille North Hospital before (V1) and 6 months (V2) after bariatric surgery

Primary Outcome Measures

Name	Time	Method
The change in EAT amount 6 months after bariatric surgery.	36 months	We thus investigated the effect of bariatric surgery on EAT in severely obese patients.

Secondary Outcome Measures

Name	Time	Method
Evaluation of 3 parameters	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

Trial Locations

Locations (1)

AP-HM; 🇫🇷 Marseille, France