Effect of a Fibrate (Fenofibrate) and a Statin (Atorvastatin) and on Endothelial Dysfunction in Diabetes Mellitus and the Metabolic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Boston University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Brachial Artery Flow-mediated Dilation
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •HDL less than 40 mg/dl for men or less than 50 mg/dl for women;
- •triglycerides greater than 150 mg/dl;
- •waist circumference greater than 40 inches for men and greater than 35 inches for women;
- •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.
Arms & Interventions
Fenofibrate First
Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second
Intervention: Fenofibrate (Drug)
Fenofibrate First
Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second
Intervention: Atorvastatin (Drug)
Atorvastatin First
Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second
Intervention: Fenofibrate (Drug)
Atorvastatin First
Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second
Intervention: Atorvastatin (Drug)
Outcomes
Primary Outcomes
Brachial Artery Flow-mediated Dilation
Time Frame: 8 weeks
Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.
Secondary Outcomes
- Serum Lipids(8 weeks)
Investigators
Joseph A. Vita
Professor of Medicine
Boston University