Effect of a Fibrate and a Statin on Endothelial Dysfunction

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Treatments: Atorvastatin; Atorvastatin Calcium; Fenofibrate

Criteria

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.