Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 10:40 PM
Study NCT ID:
NCT01277068
Status:
COMPLETED
Last Update Posted:
2015-08-24
First Post:
2011-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
Official Title:
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: