Clinical Trials Directory

Trials / Completed

CompletedNCT01449773

Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Laval University · Academic / Other
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

Summary

The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients with type 2 diabetes are now thought to be attributable to elevated intestinal production and reduced clearance. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia. However, the investigators understanding of the physiological changes that occur with n-3 PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the intestinal production of TRLs and the expression of genes regulating intestinal lipid absorption and chylomicron synthesis have not yet been examined in humans. The general objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will: * reduce TRL apoB-48 production rate and increase fractional catabolic rate of these lipoproteins, * decrease the expression of genes that regulate intestinal lipid absorption and synthesis as well as synthesis of apoB-48-containing lipoproteins, * decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTn-3 PUFAs5 capsules/day in order to provide 3 g/day of n-3 PUFAs.
DIETARY_SUPPLEMENTPlacebo5 capsules/day containing corn and soybean oil

Timeline

Start date
2008-04-01
Primary completion
2009-10-01
Completion
2013-01-01
First posted
2011-10-10
Last updated
2013-03-04

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01449773. Inclusion in this directory is not an endorsement.