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
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus focused on measuring endothelium, obesity, diabetes mellitus, dyslipidemia
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.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
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
No
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
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.
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
No
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
Learn more about this trial
Effect of a Fibrate and a Statin on Endothelial Dysfunction
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