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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

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.

Condition or disease Intervention/treatment
Diabetes Dyslipidemia Inflammation Cytokines Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : July 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: M1000 S10 F100
metformin 1000mg, fenofibrate 100mg and simvastatin 10mg
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 F267
metformin 1000mg, fenofibrate 267mg and simvastatin 10mg
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 S40 F100
metformin 1000mg, fenofibrate 100mg and simvastatin 40mg
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 S40 F267
metformin 1000mg, fenofibrate 267mg and simvastatin 40mg
Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S10 F100
metformin 2500mg, fenofibrate 100mg and simvastatin 10mg
Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S10 F267
metformin 2500mg, fenofibrate 267mg and simvastatin 10mg
Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S40 F267
metformin 2500mg, fenofibrate 267mg and simvastatin 40mg
Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Active Comparator: M2500 S40 F100
metformin 2500mg, fenofibrate 100mg and simvastatin 40mg
Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Placebo Comparator: Therapeutic Lifestyle Change
Only therapeutic lifestyle change
Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 30 days ]
    Assesed by HOMA (Homeostatic Model of Assessment)

  2. Coagulation parameters [ Time Frame: 30 days ]

    Assessed using:

    1. Fibrinogen
    2. PAI-1



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101204


Contacts
Contact: Krzysztof Labuzek, MD, PhD +48 32 252 39 02 lbuldak@gmail.com

Locations
Poland
Department of Clinical Pharmacology Not yet recruiting
Katowice, Poland, 40752
Contact: Krzysztof Labuzek, MD, PhD    +48 32 252 39 02    lbuldak@gmail.com   
Sub-Investigator: Łukasz Bułdak, MD         
Principal Investigator: Bogusław Okopień, MD, PhD         
Sub-Investigator: Krzysztof Labuzek, MD, PhD         
Sponsors and Collaborators
Medical University of Silesia

Responsible Party: Bogusław Okopień, MD PhD, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT01101204     History of Changes
Other Study ID Numbers: MSF
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Inflammation
Dyslipidemias
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases
Metformin
Simvastatin
Fenofibrate
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors