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Completed

NCT Number: NCT01277068

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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hopitaux de Marseille

Marseille, 13, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical and medical procedures

Procedure

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

Primary outcomes

  1. 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

  1. to compare the production rates of these TRL before and after the bariatric surgery

    Time frame: 36 months

    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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
First posted
Jan 14, 2011
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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