Effect of a Fibrate and a Statin on Endothelial Dysfunction

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT00491400

Run by

Boston University

People needed

28

Starts

2005-09-01

Expected to finish

2008-12-01

Last updated by the study team

2012-10-24

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.