The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines | RxWiki

The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Dyslipidemia Inflammation Cytokines
Intervention	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Phase	N/A
Sponsor	Medical University of Silesia
Responsible Party	Medical University of Silesia
ClinicalTrials.gov Identifier	NCT01101204
First Received	April 7, 2010
Last Updated	July 5, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	April 7, 2010
Last Updated Date	July 5, 2012
Start Date	July 2012
Estimated Primary Completion Date	December 2012
Current Primary Outcome Measures	Antiinflammatory effects of combined antidiabetic and hypolipemic treatment [Time Frame: 30 days] [Designated as safety issue: Yes]As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines: Interleukin 1 TNF alpha Interleukin 6 Interleukin 10 hsCRP
Current Secondary Outcome Measures	Insulin sensitivity [Time Frame: 30 days] [Designated as safety issue: Yes]Assesed by HOMA (Homeostatic Model of Assessment) Coagulation parameters [Time Frame: 30 days] [Designated as safety issue: Yes]Assessed using: Fibrinogen PAI-1

Descriptive Information[ + expand ][ + ]

Brief Title	The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines
Official Title	Effects of High and Low Doses of Metformin, Fenofibrate and Simvastatin, Administered Together and in Sequence With Lifestyle Intervention on Lipid Profile, Glucose Metabolism, Low-grade Inflammation and Hemostasis in Patient's Blood Plasma in Type 2 Diabetic Patients With Serious Mixed Dyslipidemia
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Diabetes Dyslipidemia Inflammation Cytokines
Intervention	Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Study Arm (s)	Active Comparator: M1000 S10 F100 metformin 1000mg, fenofibrate 100mg and simvastatin 10mg Active Comparator: M1000 S10 F267 metformin 1000mg, fenofibrate 267mg and simvastatin 10mg Active Comparator: M1000 S40 F100 metformin 1000mg, fenofibrate 100mg and simvastatin 40mg Active Comparator: M1000 S40 F267 metformin 1000mg, fenofibrate 267mg and simvastatin 40mg Active Comparator: M2500 S10 F100 metformin 2500mg, fenofibrate 100mg and simvastatin 10mg Active Comparator: M2500 S10 F267 metformin 2500mg, fenofibrate 267mg and simvastatin 10mg Active Comparator: M2500 S40 F267 metformin 2500mg, fenofibrate 267mg and simvastatin 40mg Active Comparator: M2500 S40 F100 metformin 2500mg, fenofibrate 100mg and simvastatin 40mg Placebo Comparator: Therapeutic Lifestyle Change Only therapeutic lifestyle change

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	200
Estimated Completion Date	December 2012
Estimated Primary Completion Date	October 2012
Eligibility Criteria	Inclusion Criteria: - Age (35-64yr) - 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: - Secondary hyperlipidemia - 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)
Gender	Both
Ages	35 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Contact: Krzysztof Labuzek, MD, PhD +48 32 252 39 02 lbuldak@gmail.com
Location Countries	Poland

Administrative Information[ + expand ][ + ]

NCT Number	NCT01101204
Other Study ID Numbers	MSF
Has Data Monitoring Committee	No
Information Provided By	Medical University of Silesia
Study Sponsor	Medical University of Silesia
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	July 2012

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