Effects of Hypolipemic Treatment on Adipokines

Medical University of Silesia

Status: Completed

Conditions: Hyperlipidemia; Impaired Fasting Glycemia

Treatments: Drug: To compare monotherapies and combined therapy with each other

Study type: Interventional

Funder types: Other

Identifiers

NCT01099176

Ministry of Science

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

78 participants in 4 patient groups, including a placebo group

Atorvastatin

Experimental group

Description:

10mg of Atorvastatin

Treatment:

Drug: To compare monotherapies and combined therapy with each other

Fenofibrate

Experimental group

Description:

267mg of Fenofibrate

Treatment:

Drug: To compare monotherapies and combined therapy with each other

Fenofibrate and atorvastatin

Experimental group

Description:

10mg of Atorvastatin and 267mg of fenofibrate

Treatment:

Drug: To compare monotherapies and combined therapy with each other

Therapeutic Lifestyle Change

Placebo Comparator group

Description:

Placebo and Therapeutic Lifestyle Change

Treatment:

Drug: To compare monotherapies and combined therapy with each other