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

Medical University of Silesia

Status: Unknown

Conditions: Inflammation; Diabetes; Cytokines; Dyslipidemia

Treatments: Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01101204

MSF

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 9 patient groups, including a placebo group

M1000 S10 F100

Active Comparator group

Description:

metformin 1000mg, fenofibrate 100mg and simvastatin 10mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

M1000 S10 F267

Active Comparator group

Description:

metformin 1000mg, fenofibrate 267mg and simvastatin 10mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

M1000 S40 F100

Active Comparator group

Description:

metformin 1000mg, fenofibrate 100mg and simvastatin 40mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

M1000 S40 F267

Active Comparator group

Description:

metformin 1000mg, fenofibrate 267mg and simvastatin 40mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

M2500 S10 F100

Active Comparator group

Description:

metformin 2500mg, fenofibrate 100mg and simvastatin 10mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

M2500 S10 F267

Active Comparator group

Description:

metformin 2500mg, fenofibrate 267mg and simvastatin 10mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

M2500 S40 F267

Active Comparator group

Description:

metformin 2500mg, fenofibrate 267mg and simvastatin 40mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

M2500 S40 F100

Active Comparator group

Description:

metformin 2500mg, fenofibrate 100mg and simvastatin 40mg

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg

Therapeutic Lifestyle Change

Placebo Comparator group

Description:

Only therapeutic lifestyle change

Treatment:

Drug: Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg