NCT01284816

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

4.8 years

First QC Date

January 26, 2011

Last Update Submit

July 23, 2015

Conditions

Severely Obese Patients

Keywords

severely obese patients

Outcome Measures

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.

    36 months

Secondary Outcomes (1)

  • Evaluation of 3 parameters

    36 months

Study Arms (1)

severely obese patients

OTHER

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

bariatric surgeryPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men or women who have more than 18 years
  • patients have been informed and have consented
  • severely obese patients with surgery indication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HM

Marseille, 13, France

Location

Related Publications (3)

  • Soghomonian A, Dutour A, Kachenoura N, Thuny F, Lasbleiz A, Ancel P, Cristofari R, Jouve E, Simeoni U, Kober F, Bernard M, Gaborit B. Is increased myocardial triglyceride content associated with early changes in left ventricular function? A 1H-MRS and MRI strain study. Front Endocrinol (Lausanne). 2023 Jun 22;14:1181452. doi: 10.3389/fendo.2023.1181452. eCollection 2023.

    PMID: 37424866DERIVED

  • Henry JA, Abdesselam I, Deal O, Lewis AJ, Rayner J, Bernard M, Dutour A, Gaborit B, Kober F, Soghomonian A, Sgromo B, Byrne J, Bege T, Neubauer S, Borlaug BA, Rider OJ. Changes in epicardial and visceral adipose tissue depots following bariatric surgery and their effect on cardiac geometry. Front Endocrinol (Lausanne). 2023 Jan 25;14:1092777. doi: 10.3389/fendo.2023.1092777. eCollection 2023.

    PMID: 36761185DERIVED

  • 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.

    PMID: 22939560DERIVED

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Anne Dutour, Professor

    AP-HM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

September 1, 2010

Primary Completion

July 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

FR(1)