Diabetes Mellitus, Metabolic Syndrome
Conditions
Keywords
endothelium, obesity, diabetes mellitus, dyslipidemia
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.
Interventions
DRUGFenofibrate
140 mg/day for 8 weeks
DRUGAtorvastatin
20 mg/day for 8 weeks
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brachial Artery Flow-mediated Dilation | 8 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Serum Lipids | 8 weeks | Effect of the intervention on total cholesterol, HDL, and triglycerides |
Countries
United States
Participant flow
Recruitment details
Patients meeting the entry criteria were recruited at Boston Medical Center.
Pre-assignment details
101 patients were consented and underwent screening. 73 were excluded because testing demonstrated that they were ineligible. 28 Entered the study 9 withdrew from the study
Participants by arm
| Arm | Count |
|---|---|
| Fenofibrate First Fenofibrate First and Atorvastatin Second | 15 |
| Atorvastatin First Atorvastatin First and Fenofibrate Second | 13 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Total | Fenofibrate First | Atorvastatin First |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 15 Participants | 13 Participants |
| Region of Enrollment United States | 28 participants | 15 participants | 13 participants |
| Sex: Female, Male Female | 19 Participants | 10 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 |
Outcome results
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.
Time frame: 8 weeks
Population: The number of participants is too few for meaningful analysis.
Secondary
Serum Lipids
Effect of the intervention on total cholesterol, HDL, and triglycerides
Time frame: 8 weeks
Population: Enrollment was insufficient and there are too few subjects for meaningful analysis