Effects of Hypolipemic Treatment on Adipokines

Not Applicable

Completed

• Conditions: Hyperlipidemia; Impaired Fasting Glycemia
• Interventions: Drug: To compare monotherapies and combined therapy with each other

• Registration Number: NCT01099176
• Lead Sponsor: Medical University of Silesia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-03
• Study Start: 2008-05
• Primary Completion: 2009-05
• Study Completion: 2009-09
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-05
• Study First Posted: 2010-04-06
• Last Update Submitted: 2010-04-08
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	To compare monotherapies and combined therapy with each other	10mg of Atorvastatin
Fenofibrate	To compare monotherapies and combined therapy with each other	267mg of Fenofibrate
Fenofibrate and atorvastatin	To compare monotherapies and combined therapy with each other	10mg of Atorvastatin and 267mg of fenofibrate
Therapeutic Lifestyle Change	To compare monotherapies and combined therapy with each other	Placebo and Therapeutic Lifestyle Change

Primary Outcome Measures

Name	Time	Method
Adipokines	Day 90	Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.

Secondary Outcome Measures

Name	Time	Method
Proinflammatory cytokines	Day 90	Interleukin-6 and TNF alpha serum concentration on the Day 90 of the treatment
Adipokines	Day 30	Serum concentration of leptin, adiponectin and resistin on Day 30 of the treatment.

Trial Locations

Locations (1)

Department of Pharmacology; 🇵🇱 Katowice, Śląskie, Poland