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

Not Applicable

Completed

• Conditions: Production Rates of These TRL Before and After the Bariatric Surgery; Obese Patients; Cardiovascular Diseases

• Registration Number: NCT01277068
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-14
• Primary Completion: 2014-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL	36 months	the 3 bariatric surgery procedures are: the adjustable gastric banding the sleeve gastrectomy the gastric bypass (associating a malabsorption).

Secondary Outcome Measures

Name	Time	Method
to compare the production rates of these TRL before and after the bariatric surgery	36 months	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 a constituent recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown

Trial Locations

Locations (1)

Assistance Publique - Hopitaux de Marseille; 🇫🇷 Marseille, France