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

This study is not yet open for participant recruitment.
Verified July 2012 by Medical University of Silesia
Sponsor:
Information provided by (Responsible Party):
Bogusław Okopień, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT01101204
First received: April 7, 2010
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  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 Intervention
Diabetes
Dyslipidemia
Inflammation
Cytokines
 Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Silesia:

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:

    1. Interleukin 1
    2. TNF alpha
    3. Interleukin 6
    4. Interleukin 10
    5. hsCRP


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:

    1. Fibrinogen
    2. PAI-1


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Bogusław Okopień, MD PhD, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT01101204     History of Changes
Other Study ID Numbers: MSF
Study First Received: April 7, 2010
Last Updated: July 5, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on October 17, 2012