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

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

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

Treatments

Procedure: Surgical and medical procedures

Study type

Interventional

Funder types

Other

Identifiers

NCT01277068
2010-A00844-35

Details and patient eligibility

About

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).

Full 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

Enrollment

36 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

36 participants in 3 patient groups

the adjustable gastric banding
Active Comparator group
Treatment:
Procedure: Surgical and medical procedures
the sleeve gastrectomy
Active Comparator group
Treatment:
Procedure: Surgical and medical procedures
the gastric bypass
Active Comparator group
Treatment:
Procedure: Surgical and medical procedures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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