Effect of a Fibrate and a Statin on Endothelial Dysfunction

Boston University

Status: Terminated

Conditions: Diabetes Mellitus; Metabolic Syndrome

Treatments: Drug: Atorvastatin; Drug: Fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00491400

H-23185

Details and patient eligibility

About

The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome.

Full description

The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome. The study is a double blind, placebo controlled, crossover study with the order of treatment randomized. Patients will receive each treatment for 8 weeks with a 1 week rest period between treatment periods. Endothelial function will be tested using non-invasive techniques before and after each treatments. A total of 40 subjects with diabetes or the metabolic syndrome will be enrolled at Boston Medical Center.

Enrollment: 28 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 30 years
• Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent) or metabolic syndrome (defined as at least 3 of the following: 1. HDL less than 40 mg/dl for men or less than 50 mg/dl for women; 2. triglycerides greater than 150 mg/dl; 3. waist circumference greater than 40 inches for men and greater than 35 inches for women; 4. fasting glucose greater than 100 mg/dl).
• LDL cholesterol level less than 140 mg/dl
• Able to provide informed consent and complete study procedures

Exclusion criteria

• Change in therapy for glucose control or blood pressure less than 1 month before entry
• Hemoglobin A1C greater than 8.0%.
• Renal insufficiency (serum creatinine greater than 1.6 mg/dl in men or 1.5 mg/dl in women.
• Any investigational drug less than 1 month before entry.
• Pregnancy (excluded by urine pregnancy test at study entry with ongoing use of reliable form of birth control) or lactation
• Liver function tests or serum creatinine kinase (CK) greater than 3 times upper limit of normal.
• Clinically evident major illnesses or other problem that would make participation inappropriate
• Clinical history of symptomatic cholelithiasis
• Patients with coronary artery disease, peripheral arterial disease, or cerebral vascular disease will not be enrolled if they are currently taking lipid-lowering therapy
• Patients taking more than 40 mg/day of atorvastatin will be excluded. There is no "ceiling" level for patients taking fibrates.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Fenofibrate First

Active Comparator group

Description:

Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second

Treatment:

Drug: Fenofibrate

Drug: Atorvastatin

Atorvastatin First

Active Comparator group

Description:

Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second

Treatment:

Drug: Fenofibrate

Drug: Atorvastatin