Effects of Hypolipemic Treatment on Adipokines

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

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 Overview

• Status: Completed
• Conditions: Hyperlipidemia; Impaired Fasting Glycemia
• Intervention / Treatment: Drug: To compare monotherapies and combined therapy with each other

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Śląskie
    • Katowice, Śląskie, Poland, 40-762
      • Department of Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atorvastatin; 10mg of Atorvastatin	Drug: To compare monotherapies and combined therapy with each other; 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
Experimental: Fenofibrate; 267mg of Fenofibrate	Drug: To compare monotherapies and combined therapy with each other; 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
Experimental: Fenofibrate and atorvastatin; 10mg of Atorvastatin and 267mg of fenofibrate	Drug: To compare monotherapies and combined therapy with each other; 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
Placebo Comparator: Therapeutic Lifestyle Change; Placebo and Therapeutic Lifestyle Change	Drug: To compare monotherapies and combined therapy with each other; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Collaborators: Ministry of Scientific Research and Information Technology, Poland

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: April 5, 2010
• First Submitted That Met QC Criteria: April 5, 2010
• First Posted (Estimate): April 6, 2010

Study Record Updates

• Last Update Posted (Estimate): April 9, 2010
• Last Update Submitted That Met QC Criteria: April 8, 2010
• Last Verified: March 1, 2006

More Information

Terms related to this study

• Keywords: fenofibrate; atorvastatin; hyperlipidemia; adipokines; impaired fasting glycemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: Ministry of Science