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The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines (MSF)

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ClinicalTrials.gov Identifier: NCT01101204
Recruitment Status : Unknown
Verified July 2012 by Bogusław Okopień, Medical University of Silesia.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2010
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Bogusław Okopień, Medical University of Silesia

April 7, 2010
April 9, 2010
July 9, 2012
July 2012
October 2012   (Final data collection date for primary outcome measure)
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment [ Time Frame: 30 days ]

As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines:

  1. Interleukin 1
  2. TNF alpha
  3. Interleukin 6
  4. Interleukin 10
  5. hsCRP
Same as current
Complete list of historical versions of study NCT01101204 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity [ Time Frame: 30 days ]
    Assesed by HOMA (Homeostatic Model of Assessment)
  • Coagulation parameters [ Time Frame: 30 days ]

    Assessed using:

    1. Fibrinogen
    2. PAI-1
Same as current
Not Provided
Not Provided
 
The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines
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
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Diabetes
  • Dyslipidemia
  • Inflammation
  • Cytokines
Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
  • Active Comparator: M1000 S10 F100
    metformin 1000mg, fenofibrate 100mg and simvastatin 10mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Active Comparator: M1000 S10 F267
    metformin 1000mg, fenofibrate 267mg and simvastatin 10mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Active Comparator: M1000 S40 F100
    metformin 1000mg, fenofibrate 100mg and simvastatin 40mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Active Comparator: M1000 S40 F267
    metformin 1000mg, fenofibrate 267mg and simvastatin 40mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Active Comparator: M2500 S10 F100
    metformin 2500mg, fenofibrate 100mg and simvastatin 10mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Active Comparator: M2500 S10 F267
    metformin 2500mg, fenofibrate 267mg and simvastatin 10mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Active Comparator: M2500 S40 F267
    metformin 2500mg, fenofibrate 267mg and simvastatin 40mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Active Comparator: M2500 S40 F100
    metformin 2500mg, fenofibrate 100mg and simvastatin 40mg
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
  • Placebo Comparator: Therapeutic Lifestyle Change
    Only therapeutic lifestyle change
    Intervention: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
December 2012
October 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
35 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01101204
MSF
No
Not Provided
Not Provided
Bogusław Okopień, Medical University of Silesia
Medical University of Silesia
Not Provided
Not Provided
Medical University of Silesia
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP