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Effects of Hypolipemic Treatment on Adipokines

Primary Purpose

Hyperlipidemia, Impaired Fasting Glycemia

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
To compare monotherapies and combined therapy with each other
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperlipidemia focused on measuring hyperlipidemia, impaired fasting glycemia, adipokines, atorvastatin, fenofibrate

Eligibility Criteria

35 Years - 64 Years (Adult)All SexesAccepts 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)

Sites / Locations

  • Department of Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Fenofibrate

Fenofibrate and atorvastatin

Therapeutic Lifestyle Change

Arm Description

10mg of Atorvastatin

267mg of Fenofibrate

10mg of Atorvastatin and 267mg of fenofibrate

Placebo and Therapeutic Lifestyle Change

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proinflammatory cytokines
Interleukin-6 and TNF alpha serum concentration on the Day 30 of the treatment
Adipokines
Serum concentration of leptin, adiponectin and resistin on Day 30 of the treatment.
Proinflammatory cytokines
Interleukin-6 and TNF alpha serum concentration on the Day 90 of the treatment

Full Information

First Posted
April 5, 2010
Last Updated
April 8, 2010
Sponsor
Medical University of Silesia
Collaborators
Ministry of Scientific Research and Information Technology, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT01099176
Brief Title
Effects of Hypolipemic Treatment on Adipokines
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Silesia
Collaborators
Ministry of Scientific Research and Information Technology, Poland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Impaired Fasting Glycemia
Keywords
hyperlipidemia, impaired fasting glycemia, adipokines, atorvastatin, fenofibrate

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
10mg of Atorvastatin
Arm Title
Fenofibrate
Arm Type
Experimental
Arm Description
267mg of Fenofibrate
Arm Title
Fenofibrate and atorvastatin
Arm Type
Experimental
Arm Description
10mg of Atorvastatin and 267mg of fenofibrate
Arm Title
Therapeutic Lifestyle Change
Arm Type
Placebo Comparator
Arm Description
Placebo and Therapeutic Lifestyle Change
Intervention Type
Drug
Intervention Name(s)
To compare monotherapies and combined therapy with each other
Intervention Description
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 Outcome Measure Information:
Title
Adipokines
Description
Serum concentration of leptin, adiponectin and resistin on Day 90 of the treatment.
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Proinflammatory cytokines
Description
Interleukin-6 and TNF alpha serum concentration on the Day 30 of the treatment
Time Frame
Day 30
Title
Adipokines
Description
Serum concentration of leptin, adiponectin and resistin on Day 30 of the treatment.
Time Frame
Day 30
Title
Proinflammatory cytokines
Description
Interleukin-6 and TNF alpha serum concentration on the Day 90 of the treatment
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Department of Pharmacology
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-762
Country
Poland

12. IPD Sharing Statement

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Effects of Hypolipemic Treatment on Adipokines

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