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OpenTrials
Completed

NCT Number: NCT01099176

Effects of Hypolipemic Treatment on 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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Impaired Fasting Glycemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pharmacology

Katowice, Silesian Voivodeship, 40-762, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

To compare monotherapies and combined therapy with each other

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

Primary outcomes

  1. Adipokines

    Time frame: Day 90

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

Secondary outcomes

  1. Proinflammatory cytokines

    Time frame: Day 30

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

  2. Adipokines

    Time frame: Day 30

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

  3. Proinflammatory cytokines

    Time frame: Day 90

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

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Ministry of Scientific Research and Information Technology, Poland

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 6, 2010
Registry last updated
Apr 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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