Status:
COMPLETED
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
Lead Sponsor:
Laval University
Conditions:
Type 2 Diabetes
Eligibility:
MALE
18-55 years
Phase:
NA
Brief 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 clea...
Eligibility Criteria
Inclusion
- age between 18 and 55 years,
- plasma TG levels above the 50th percentile for age,
- non-smoker,
- BMI between 25.0 and 40.0 kg/m2,
- stable body weight for at least 6 months prior to the study baseline,
- HbA1c between 6.5 and 8.5%,
- baseline fasting plasma glucose \< 15.0 mmol/L
- patients with de novo type 2 diabetes not taking oral hypoglycemic agents -- - or patients having received stable doses of metformin for at least 3 months before randomization.
Exclusion
- extreme dyslipidemias such as familial hypercholesterolemia,
- patients with secondary form of diabetes or acute metabolic diabetic complications,
- patients having received or being treated with insulin or a thiazolidinedione within the past 6 months,
- subjects having CVD (CHD, cerebrovascular disease or peripheral arterial disease)
- subjects taking medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents,
- significant alcohol intake
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01449773
Start Date
April 1 2008
End Date
January 1 2013
Last Update
March 4 2013
Active Locations (1)
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1
Laval University
Québec, Quebec, Canada, G1V 0A6