NCT01277068

Brief Summary

Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In front of this important overmortality, the bariatric surgery quickly developed. Three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

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
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

4 years

First QC Date

January 13, 2011

Last Update Submit

August 21, 2015

Conditions

Obese PatientsProduction Rates of These TRL Before and After the Bariatric SurgeryCardiovascular Diseases

Keywords

obese patientsTRLthe bariatric surgery

Outcome Measures

Primary Outcomes (1)

  • to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL

    the 3 bariatric surgery procedures are: the adjustable gastric banding the sleeve gastrectomy the gastric bypass (associating a malabsorption).

    36 months

Secondary Outcomes (1)

  • to compare the production rates of these TRL before and after the bariatric surgery

    36 months

Study Arms (3)

the adjustable gastric banding

ACTIVE COMPARATOR
Procedure: Surgical and medical procedures

the sleeve gastrectomy

ACTIVE COMPARATOR
Procedure: Surgical and medical procedures

the gastric bypass

ACTIVE COMPARATOR
Procedure: Surgical and medical procedures

Interventions

Surgical and medical proceduresPROCEDURE

this study want to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL: the adjustable gastric banding the sleeve gastrectomy the gastric bypass

the adjustable gastric bandingthe gastric bypassthe sleeve gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Men or women from 18 to 65 years old
  • Subject having a BMI included between 35 and 40 kg / m2 associated to at least a comorbidity susceptible to be improved after the surgery
  • Subject in failure of a medical treatment, led by an expert in nutrition, associating a dietary coverage and a physical activity adapted for at least 6 months
  • Subject without contraindication for 3 studied surgical techniques
  • Subject without cardiovascular events 6 months ago
  • subject is informed and is consented
  • Subject having a biologic balance dating less than 3 months

You may not qualify if:

  • subject with contraindication for 3 studied surgical techniques
  • women pregnant
  • subject did not consent and is not informed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hopitaux de Marseille

Marseille, 13, France

Location

Related Publications (2)

  • Frances L, Croyal M, Ruidavets JB, Maraninchi M, Combes G, Raffin J, de Souto Barreto P, Ferrieres J, Blaak EE, Perret B, Moro C, Valero R, Martinez LO, Viguerie N. Identification of circulating apolipoprotein M as a new determinant of insulin sensitivity and relationship with adiponectin. Int J Obes (Lond). 2024 Jul;48(7):973-980. doi: 10.1038/s41366-024-01510-w. Epub 2024 Mar 15.

    PMID: 38491190DERIVED

  • Padilla N, Maraninchi M, Beliard S, Berthet B, Nogueira JP, Wolff E, Nicolay A, Begu A, Dubois N, Grangeot R, Mattei C, Vialettes B, Xiao C, Lewis GF, Valero R. Effects of bariatric surgery on hepatic and intestinal lipoprotein particle metabolism in obese, nondiabetic humans. Arterioscler Thromb Vasc Biol. 2014 Oct;34(10):2330-7. doi: 10.1161/ATVBAHA.114.303849. Epub 2014 Aug 7.

    PMID: 25104797DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Surgical Procedures, OperativeMethods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • René Valero, Professor

    APHM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 14, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2014

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

FR(1)