Skip to main content
Clinical Trials/NCT01277068
NCT01277068
Completed
Not Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country36 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obese Patients
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
36
Locations
1
Primary Endpoint
to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL
Status
Completed
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 36 months

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

Secondary Outcomes

  • to compare the production rates of these TRL before and after the bariatric surgery(36 months)

Study Sites (1)

Loading locations...

Similar Trials