Clinical trial NCT01277068: Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
Official title: Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Patients
Production Rates of These TRL Before and After the Bariatric Surgery
Cardiovascular Diseases
Keywords: obese patients
TRL
the bariatric surgery
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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).

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL
timeFrame: 36 months
Secondary outcomes:
measure: to compare the production rates of these TRL before and after the bariatric surgery
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
Study officials:
affiliation: APHM
name: René Valero, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.