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Effect of a Fibrate and a Statin on Endothelial Dysfunction

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT00491400
First received: June 22, 2007
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Metabolic Syndrome
 Drug: Fenofibrate
Drug: Atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of a Fibrate (Fenofibrate) and a Statin (Atorvastatin) and on Endothelial Dysfunction in Diabetes Mellitus and the Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial Artery Flow-mediated Dilation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Serum Lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Effect of the intervention on total cholesterol, HDL, and triglycerides


Enrollment: 28
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fenofibrate First
Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second
 Drug: Fenofibrate
140 mg/day for 8 weeks
Other Name: Tricor
Drug: Atorvastatin
20 mg/day for 8 weeks
Other Name: Lipitor
Active Comparator: Atorvastatin First
Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second
 Drug: Fenofibrate
140 mg/day for 8 weeks
Other Name: Tricor
Drug: Atorvastatin
20 mg/day for 8 weeks
Other Name: Lipitor

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491400

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston University
  More Information

No publications provided

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT00491400     History of Changes
Other Study ID Numbers: H-23185
Study First Received: June 22, 2007
Results First Received: May 23, 2012
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
endothelium
obesity
diabetes mellitus
dyslipidemia

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Fenofibrate
Atorvastatin
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013