Effects of Hypolipemic Treatment on Adipokines

NCT ID: NCT01099176

Last Updated: 2010-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-09-30

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.

Conditions

Hyperlipidemia; Impaired Fasting Glycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Atorvastatin

10mg of Atorvastatin

Group Type: EXPERIMENTAL

To compare monotherapies and combined therapy with each other

Intervention Type: DRUG

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

Fenofibrate

267mg of Fenofibrate

Group Type: EXPERIMENTAL

To compare monotherapies and combined therapy with each other

Intervention Type: DRUG

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

Fenofibrate and atorvastatin

10mg of Atorvastatin and 267mg of fenofibrate

Group Type: EXPERIMENTAL

To compare monotherapies and combined therapy with each other

Intervention Type: DRUG

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

Therapeutic Lifestyle Change

Placebo and Therapeutic Lifestyle Change

Group Type: PLACEBO_COMPARATOR

To compare monotherapies and combined therapy with each other

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Scientific Research and Information Technology, Poland

OTHER_GOV

Sponsor Role: collaborator

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Medical University of Silesia, Dept. of Pharmacology

Locations

Department of Pharmacology

Katowice, Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

Ministry of Science

Identifier Type: -

Identifier Source: org_study_id