The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Silesia
• Treatments: Fenofibrate; Metformin; Simvastatin

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)