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:
Assistance Publique Hopitaux De Marseille
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
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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 2013 (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
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: | AP HM, Direction de la recherche |
| ClinicalTrials.gov Identifier: | NCT01277068 History of Changes |
| Other Study ID Numbers: | 2010-A00844-35 |
| Study First Received: | January 13, 2011 |
| Last Updated: | March 31, 2011 |
| 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 Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013