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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01099176

Enrollment

Registered

2010-04-06

Start date

2008-05-31

Completion date

2009-09-30

Last updated

2010-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Impaired Fasting Glycemia

Keywords

hyperlipidemia, impaired fasting glycemia, adipokines, atorvastatin, fenofibrate

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.

Interventions

DRUGTo 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

35 Years to 64 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Adipokines	Day 90	Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.

Secondary

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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026