Clinical trial NCT00491400: Effect of a Fibrate and a Statin on Endothelial Dysfunction
Official title: Effect of a Fibrate (Fenofibrate) and a Statin (Atorvastatin) and on Endothelial Dysfunction in Diabetes Mellitus and the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Metabolic Syndrome
Keywords: endothelium
obesity
diabetes mellitus
dyslipidemia
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2007-06-26
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Brachial Artery Flow-mediated Dilation
timeFrame: 8 weeks
Secondary outcomes:
measure: Serum Lipids
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Joseph A Vita, MD
role: PRINCIPAL_INVESTIGATOR
References: