Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients

NCT ID: NCT01277068

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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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).

Detailed Description

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It is a monocentric, prospective, comparative study. After identification of the eligible subjects, the kinetics (production and clearance rates) of the intestinal TRL will be performed in the hospital, using a stable isotope method (5,5,5-D3-L-Leucine), in 3 groups of obese patients (12 patients per surgery procedure), before and 6 months after the surgery

Conditions

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Obese Patients Production Rates of These TRL Before and After the Bariatric Surgery Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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the adjustable gastric banding

Group Type ACTIVE_COMPARATOR

Surgical and medical procedures

Intervention Type PROCEDURE

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 sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

Surgical and medical procedures

Intervention Type PROCEDURE

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 gastric bypass

Group Type ACTIVE_COMPARATOR

Surgical and medical procedures

Intervention Type PROCEDURE

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

Interventions

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Surgical and medical procedures

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* subject with contraindication for 3 studied surgical techniques
* women pregnant
* subject did not consent and is not informed
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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René Valero, Professor

Role: PRINCIPAL_INVESTIGATOR

APHM

Locations

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Assistance Publique - Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 38491190 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25104797 (View on PubMed)

Other Identifiers

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2010-A00844-35

Identifier Type: -

Identifier Source: org_study_id

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