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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277068
• Other study ID #: 2010-A00844-35
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: August 21, 2015
• Start date: September 2010

Study information

• Verified date: August 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	to compare the production rates of these TRL before and after the bariatric surgery	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	36 months	No