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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Diabetes; Dyslipidemia; Cytokines
• Intervention / Treatment: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krzysztof Labuzek, MD, PhD; Phone Number: +48 32 252 39 02; Email: lbuldak@gmail.com

Study Locations

• Poland
  • Katowice, Poland, 40752
    • Department of Clinical Pharmacology
    • Contact: Krzysztof Labuzek, MD, PhD; Phone Number: +48 32 252 39 02; Email: lbuldak@gmail.com
    • Sub-Investigator: Łukasz Bułdak, MD
    • Principal Investigator: Bogusław Okopień, MD, PhD
    • Sub-Investigator: Krzysztof Labuzek, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	Assesed by HOMA (Homeostatic Model of Assessment)	30 days
Coagulation parameters	Assessed using: Fibrinogen; PAI-1	30 days

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): July 9, 2012
• Last Update Submitted That Met QC Criteria: July 5, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Lipid Metabolism Disorders; Inflammation; Dyslipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Metformin; Simvastatin; Fenofibrate
• Other Study ID Numbers: MSF