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CompletedNCT01284816Updated Jul 24, 2015

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

An interventional study of bariatric surgery in Severely Obese Patients, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-24.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
44
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Severely Obese Patients

Keywords

  • severely obese patients
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In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • 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

Interventions

  • Procedurebariatric 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.

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What researchers measure

Primary outcomes

  1. The change in EAT amount 6 months after bariatric surgery.

    We thus investigated the effect of bariatric surgery on EAT in severely obese patients.

    Time frame: 36 months

Secondary outcomes

  1. Evaluation of 3 parameters

    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

    Time frame: 36 months

07

Study locations

1 site
  • AP-HM
    Marseille, 13, France
08

References and documents

Publications

  • Gaborit B, Jacquier A, Kober F, Abdesselam I, Cuisset T, Boullu-Ciocca S, Emungania O, Alessi MC, Clement K, Bernard M, Dutour A. Effects of bariatric surgery on cardiac ectopic fat: lesser decrease in epicardial fat compared to visceral fat loss and no change in myocardial triglyceride content. J Am Coll Cardiol. 2012 Oct 9;60(15):1381-9. doi: 10.1016/j.jacc.2012.06.016. Epub 2012 Aug 29. PubMed 22939560 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01284816
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jan 27, 2011
Start date
Sep 2010
Primary completion
Jul 2015
Last update
Jul 24, 2015

Study contacts

Anne Dutour, Professor
principal investigator · AP-HM

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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