The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines
NCT ID: NCT01101204
Last Updated: 2012-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2012-07-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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M1000 S10 F100
metformin 1000mg, fenofibrate 100mg and simvastatin 10mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
M1000 S10 F267
metformin 1000mg, fenofibrate 267mg and simvastatin 10mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
M1000 S40 F100
metformin 1000mg, fenofibrate 100mg and simvastatin 40mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
M1000 S40 F267
metformin 1000mg, fenofibrate 267mg and simvastatin 40mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
M2500 S10 F100
metformin 2500mg, fenofibrate 100mg and simvastatin 10mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
M2500 S10 F267
metformin 2500mg, fenofibrate 267mg and simvastatin 10mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
M2500 S40 F267
metformin 2500mg, fenofibrate 267mg and simvastatin 40mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
M2500 S40 F100
metformin 2500mg, fenofibrate 100mg and simvastatin 40mg
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Therapeutic Lifestyle Change
Only therapeutic lifestyle change
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Interventions
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Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Eligibility Criteria
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Inclusion Criteria
* Primary hyperlipidemia (Total cholesterol \>200mg/dl, Triglycerides \>150mg/dl)
* Type 2 Diabetes
* For women:
* Menopause (\>12 months)
* Post hysterectomy
* Mechanical contraception
* Obtained informed consent
Exclusion Criteria
* Morbid obesity (BMI\>40kg/m2)
* Alcohol or drug abuse
* Acute or chronic inflammation
* Congestive Heart Failure (NYHA III or IV)
* Unstable Ischaemic Heart Disease
* Moderate or severe hypertension
* Cancer in less than 5 years
* Chronic kidney disease (stage III-V)
* Liver failure
* Oral contraception
* Not compliant patient
* Laboratory results:
* alanine transferase (\>3xULN)
* creatine kinase (\>5xULN)
* haemoglobin (\<10/dl)
* PLT (\<100G/l)
* WBC (\<3,5G/l or \>10G/l)
35 Years
64 Years
ALL
Yes
Sponsors
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Medical University of Silesia
OTHER
Responsible Party
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Bogusław Okopień
MD PhD
Locations
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Department of Clinical Pharmacology
Katowice, Katowice, Poland
Countries
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Central Contacts
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Facility Contacts
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Krzysztof Labuzek, MD, PhD
Role: primary
Other Identifiers
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MSF
Identifier Type: -
Identifier Source: org_study_id