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Insufficient enrollment
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate First | Active Comparator | Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second |
|
| Atorvastatin First | Active Comparator | Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | 140 mg/day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Lipids | Effect of the intervention on total cholesterol, HDL, and triglycerides | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A Vita, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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
Patients meeting the entry criteria were recruited at Boston Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fenofibrate First | Participants randomized to receive fenofibrate first and atorvastatin second |
| FG001 | Atorvastatin First | Participants randomized to receive atorvastatin first and fenofibrate second |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fenofibrate First | Fenofibrate First and Atorvastatin Second |
| BG001 | Atorvastatin First | Atorvastatin First and Fenofibrate Second |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants is too few for meaningful analysis. | Posted | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fenofibrate First | Fenofibrate First and Atorvastatin Second |
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Early termination due to inadequate enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph A. Vita, MD | Boston University | 617-638-8700 | jvita@bu.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Atorvastatin | Drug | 20 mg/day for 8 weeks |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Serum Lipids | Effect of the intervention on total cholesterol, HDL, and triglycerides | Enrollment was insufficient and there are too few subjects for meaningful analysis | Posted | 8 weeks |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Atorvastatin First | Atorvastatin First and Fenofibrate Second | 0 | 13 | 0 | 13 |
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| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052439 | Lipid Metabolism Disorders |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |