Effect of a Fibrate and a Statin on Endothelial Dysfunction
Effect of a Fibrate and a Statin on Endothelial Dysfunction
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 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.
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.