MedDataX Logo

Effect of a Fibrate and a Statin on Endothelial Dysfunction

NCT ID: NCT00491400

Last Updated: 2012-10-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Metabolic Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

endothelium obesity diabetes mellitus dyslipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fenofibrate First

Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second

Group Type ACTIVE_COMPARATOR

Fenofibrate

Intervention Type DRUG

140 mg/day for 8 weeks

Atorvastatin

Intervention Type DRUG

20 mg/day for 8 weeks

Atorvastatin First

Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second

Group Type ACTIVE_COMPARATOR

Fenofibrate

Intervention Type DRUG

140 mg/day for 8 weeks

Atorvastatin

Intervention Type DRUG

20 mg/day for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fenofibrate

140 mg/day for 8 weeks

Intervention Type DRUG

Atorvastatin

20 mg/day for 8 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tricor Lipitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joseph A. Vita

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph A Vita, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-23185

Identifier Type: -

Identifier Source: org_study_id