Effect of a Fibrate and a Statin on Endothelial Dysfunction

Condition(s) targeted: Diabetes Mellitus; Metabolic Syndrome

Intervention: Fenofibrate (Drug); Atorvastatin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Boston University

Official(s) and/or principal investigator(s):
Joseph A Vita, MD, Principal Investigator, Affiliation: Boston University

Overall contact:
Monika Holbrook, MS, Email: monica.holbrook@bmc.org

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.

Official title: Effect of a Fibrate (Fenofibrate) and a Statin (Atorvastatin) and on Endothelial Dysfunction in Diabetes Mellitus and the Metabolic Syndrome

Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome: Brachial artery flow-mediated dilation

Secondary outcome:

Serum lipids

Markers of inflammation

Detailed 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.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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.

Monika Holbrook, MS, Email: monica.holbrook@bmc.org

Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Joseph A Vita, MD, Principal Investigator

Starting date: September 2005
Ending date: December 2008
Last updated: December 10, 2007