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Completed

NCT Number: NCT01284816

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.

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Key information

Conditions

Severely Obese Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HM

Marseille, 13, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluation of 3 parameters

    Time frame: 36 months

    • to evaluate the variation in myocardial, hepatic , pancreatic and triglyceride content
    • to evaluate the variation in left ventricular function or myocardial function
    • and to describe the relationships between changes in visceral abdominal fat, subcutaneous fat and epicardial fat

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
First posted
Jan 27, 2011
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.