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The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M1000 S10 F100 | Active Comparator | metformin 1000mg, fenofibrate 100mg and simvastatin 10mg |
|
| M1000 S10 F267 | Active Comparator | metformin 1000mg, fenofibrate 267mg and simvastatin 10mg |
|
| M1000 S40 F100 | Active Comparator | metformin 1000mg, fenofibrate 100mg and simvastatin 40mg |
|
| M1000 S40 F267 | Active Comparator | metformin 1000mg, fenofibrate 267mg and simvastatin 40mg |
|
| M2500 S10 F100 | Active Comparator | metformin 2500mg, fenofibrate 100mg and simvastatin 10mg |
|
| M2500 S10 F267 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg | Drug | Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antiinflammatory effects of combined antidiabetic and hypolipemic treatment | As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Assesed by HOMA (Homeostatic Model of Assessment) | 30 days |
| Coagulation parameters | Assessed using:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krzysztof Labuzek, MD, PhD | Contact | +48 32 252 39 02 | lbuldak@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology | Katowice | Katowice | 40752 | Poland |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D019821 | Simvastatin |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D008148 |
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metformin 2500mg, fenofibrate 267mg and simvastatin 10mg |
|
| M2500 S40 F267 | Active Comparator | metformin 2500mg, fenofibrate 267mg and simvastatin 40mg |
|
| M2500 S40 F100 | Active Comparator | metformin 2500mg, fenofibrate 100mg and simvastatin 40mg |
|
| Therapeutic Lifestyle Change | Placebo Comparator | Only therapeutic lifestyle change |
|
| 30 days |
| D052439 | Lipid Metabolism Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D010636 | Phenols |
| D007659 | Ketones |