Efficacy of fenofibrate treatment on the insulin sensitivity and pancreas ß-cell function in obese patients with hypertriglyceridemia.

• Conditions: Patients non-diabetic, obese with hypertriglyceridemia (previously untreated with fibrate).

• Registration Number: EUCTR2005-005698-31-HU
• Lead Sponsor: ational Medical Center (Országos Gyógyintézeti Központ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects with a diagnosis of meeting all criteria listed below will be included in the study:
· Age range 25 - 60 years,
· Gender: male and female,
· Hypertriglyceridemia > 1.7 mmol/L, but < 11 mmol/L,
· BMI from 30 to 40 kg/m2 and waist circumference of > 102 cm in male, and 88 cm in female,
· Patients with normal renal and liver function,
· Written informed consent obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Subjects with abnormal results on blood lab tests of hepatic and renal function (ALT > 1.5 x ULN, creatinine > 130 µmol/L),
· History of previous or existing cardiovascular disease,
· Diabetes mellitus (type 1 or 2),
· Previously treated with fibrates,
· With known cholelithiasis in absence of cholecystectomy,
· Any kind of neoplasm or malignancies,
· Pharmacologically treated hyperlipidemia or oral anticoagulant treatment within 3 months before screening,
· Patient suspected with non-compliance,
· History of alcohol and/or any drug abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effects of 145 mg NFE fenofibrate treatment compare with placebo on insulin sensitivity and the ß-cell function by Botnia-clamp method in obese, non-diabetic patients with hypertriglyceridemia. ;Secondary Objective: To measure ADMA, adiponectin, homocysteine, CRP and VEGF1 levels during fenofibrate treatment.;Primary end point(s): Percent change from baseline in M-value (a measure of insulin sensitivity obtained during the euglycaemic clamp) and Disposition Index (a measure of insulin secretion obtained during the intravenous glucose tolerance test -IVGTT-) will be presented by treatment group.