Overview

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)