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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01277068
First received: January 13, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention
Obese Patients
Production Rates of These TRL Before and After the Bariatric Surgery
Cardiovascular Diseases
Procedure: Surgical and medical procedures

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    the 3 bariatric surgery procedures are: the adjustable gastric banding the sleeve gastrectomy the gastric bypass (associating a malabsorption).


Secondary Outcome Measures:
  • to compare the production rates of these TRL before and after the bariatric surgery [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 36
Study Start Date: September 2010
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: the adjustable gastric banding 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
Active Comparator: the sleeve gastrectomy 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
Active Comparator: the gastric bypass 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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277068

Contacts
Contact: René Valero, Professor +33491387577 rene.valero@ap-hm.fr

Locations
France
Assistance Publique - Hopitaux de Marseille Recruiting
Marseille, France, 13
Contact: René Valero, Professor    +33491387577    rene.valero@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: René Valero, Professor APHM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01277068     History of Changes
Other Study ID Numbers: 2010-A00844-35
Study First Received: January 13, 2011
Last Updated: August 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
obese patients
TRL
the bariatric surgery

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014