The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

Not Applicable

• Conditions: Diabetes; Dyslipidemia; Inflammation; Cytokines
• Interventions: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

• Registration Number: NCT01101204
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Status Verified: 2012-07
• Study Start: 2012-07
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-09
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M1000 S40 F100	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 1000mg, fenofibrate 100mg and simvastatin 40mg
M1000 S40 F267	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 1000mg, fenofibrate 267mg and simvastatin 40mg
M2500 S10 F100	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 2500mg, fenofibrate 100mg and simvastatin 10mg
M2500 S10 F267	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 2500mg, fenofibrate 267mg and simvastatin 10mg
M1000 S10 F100	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 1000mg, fenofibrate 100mg and simvastatin 10mg
M1000 S10 F267	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 1000mg, fenofibrate 267mg and simvastatin 10mg
M2500 S40 F267	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 2500mg, fenofibrate 267mg and simvastatin 40mg
M2500 S40 F100	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	metformin 2500mg, fenofibrate 100mg and simvastatin 40mg
Therapeutic Lifestyle Change	Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg	Only therapeutic lifestyle change

Primary Outcome Measures

Name	Time	Method
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment	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

Name	Time	Method
Insulin sensitivity	30 days	Assesed by HOMA (Homeostatic Model of Assessment)
Coagulation parameters	30 days	Assessed using: 1. Fibrinogen; 2. PAI-1

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇵🇱 Katowice, Poland