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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005698-31-HU

Enrollment

Registered

2006-02-08

Start date

2006-09-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Lipanthyl 145mg Product Name: Fenofibrate 145mg Product Code: LF178P Pharmaceutical Form: Film-coated tablet INN or Proposed INN: fenofibrate CAS Number: 49562-28-9 Current Sponsor code: L

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026