Effects of Hypolipemic Treatment on Adipokines

Medical University of Silesia78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Hyperlipidemia Impaired Fasting Glycemia

Interventions

To compare monotherapies and combined therapy with each otherDRUG

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Department of Pharmacology

Katowice, Silesian Voivodeship, Poland

Outcomes

Primary Outcomes

Adipokines

Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.

Time frame: Day 90

Secondary Outcomes

Proinflammatory cytokines

Interleukin-6 and TNF alpha serum concentration on the Day 30 of the treatment

Time frame: Day 30

Adipokines

Serum concentration of leptin, adiponectin and resistin on Day 30 of the treatment.

Time frame: Day 30

Proinflammatory cytokines

Interleukin-6 and TNF alpha serum concentration on the Day 90 of the treatment

Time frame: Day 90

Data from ClinicalTrials.gov

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