Effect of a Fibrate and a Statin on Endothelial Dysfunction

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00491400
• Other study ID #: H-23185
• Status: Terminated
• Phase: N/A
• First received: June 22, 2007
• Last updated: September 24, 2012
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2012
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• Fenofibrate
140 mg/day for 8 weeks
• Atorvastatin
20 mg/day for 8 weeks

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial Artery Flow-mediated Dilation	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.	8 weeks	No
Secondary	Serum Lipids	Effect of the intervention on total cholesterol, HDL, and triglycerides	8 weeks	No