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Effect of a Fibrate and a Statin on Endothelial Dysfunction

Primary Purpose

Diabetes Mellitus, Metabolic Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fenofibrate

Atorvastatin

About this trial

This is an interventional basic science trial for Diabetes Mellitus focused on measuring endothelium, obesity, diabetes mellitus, dyslipidemia

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Fenofibrate First

Atorvastatin First

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serum Lipids

Effect of the intervention on total cholesterol, HDL, and triglycerides

Full Information

NCT ID

NCT00491400

First Posted

June 22, 2007

Last Updated

September 24, 2012

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT00491400

Brief Title

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

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Terminated

Why Stopped

Insufficient enrollment

Study Start Date

September 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Metabolic Syndrome

Keywords

endothelium, obesity, diabetes mellitus, dyslipidemia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fenofibrate First

Arm Type

Active Comparator

Arm Description

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

Arm Title

Atorvastatin First

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fenofibrate

Other Intervention Name(s)

Tricor

Intervention Description

140 mg/day for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

20 mg/day for 8 weeks

Primary Outcome Measure Information:

Title

Brachial Artery Flow-mediated Dilation

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Serum Lipids

Description

Effect of the intervention on total cholesterol, HDL, and triglycerides

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph A Vita, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

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Effect of a Fibrate and a Statin on Endothelial Dysfunction

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