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

This study is currently recruiting participants.
Verified March 2011 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01277068
First received: January 13, 2011
Last updated: March 31, 2011
Last verified: March 2011
History of Changes

January 13, 2011
March 31, 2011
September 2010
September 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01277068 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients

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).

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
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Obese Patients
  • Production Rates of These TRL Before and After the Bariatric Surgery
  • Cardiovascular Diseases
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 adjustable gastric banding
    Intervention: Procedure: Surgical and medical procedures
  • Active Comparator: the sleeve gastrectomy
    Intervention: Procedure: Surgical and medical procedures
  • Active Comparator: the gastric bypass
    Intervention: Procedure: Surgical and medical procedures
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: René Valero, Professor +33491387577 rene.valero@ap-hm.fr
France
 
NCT01277068
2010-A00844-35
No
AP HM, Direction de la recherche
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: René Valero, Professor APHM
Assistance Publique Hopitaux De Marseille
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP