Effects of Hypolipemic Treatment on Adipokines

Study Overview
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Brief Summary
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The study is planned to show whether monotherapies or combined hypolipemic therapy influence the fasting plasma glucose, serum adipokines (leptin, adiponectin, resistin) and proinflammatory cytokines (interleukin-6, TNF alpha) during 30 and 90 day course.

Official Title
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The Effects of 90-day Monotherapies With Atorvastatin, Fenofibrate and Combined Therapy With Atorvastatin and Fenofibrate on Lipid Profile, Fasting Plasma Glucose, Proinflammatory Cytokines and Adipokines

Conditions
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Hyperlipidemia, Impaired Fasting Glycemia

Intervention / Treatment
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* Drug: To compare monotherapies and combined therapy with each other


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (35-64yr) Primary hyperlipidemia (Total cholesterol >200mg/dl, Triglycerides >150mg/dl) Impaired fasting glycemia (glycemia 100-125mg/dl) 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 Diabetes 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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>10mg of Atorvastatin | Drug: To compare monotherapies and combined therapy with each other<br>* Each patient received two tablets per day. Time interval between pills - 12 hours. In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets<br>|
| Experimental: Fenofibrate<br>267mg of Fenofibrate | Drug: To compare monotherapies and combined therapy with each other<br>* Each patient received two tablets per day. Time interval between pills - 12 hours. In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets<br>|
| Experimental: Fenofibrate and atorvastatin<br>10mg of Atorvastatin and 267mg of fenofibrate | Drug: To compare monotherapies and combined therapy with each other<br>* Each patient received two tablets per day. Time interval between pills - 12 hours. In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets<br>|
| Placebo Comparator: Therapeutic Lifestyle Change<br>Placebo and Therapeutic Lifestyle Change | Drug: To compare monotherapies and combined therapy with each other<br>* Each patient received two tablets per day. Time interval between pills - 12 hours. In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adipokines | Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment. | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proinflammatory cytokines | Interleukin-6 and TNF alpha serum concentration on the Day 30 of the treatment | Day 30 | 
| Adipokines | Serum concentration of leptin, adiponectin and resistin on Day 30 of the treatment. | Day 30 | 
| Proinflammatory cytokines | Interleukin-6 and TNF alpha serum concentration on the Day 90 of the treatment | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperlipidemia, impaired fasting glycemia, adipokines, atorvastatin, fenofibrate