NCT01099176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
Last Updated

April 9, 2010

Status Verified

March 1, 2006

Enrollment Period

1 year

First QC Date

April 5, 2010

Last Update Submit

April 8, 2010

Conditions

HyperlipidemiaImpaired Fasting Glycemia

Keywords

hyperlipidemiaimpaired fasting glycemiaadipokinesatorvastatinfenofibrate

Outcome Measures

Primary Outcomes (1)

  • Adipokines

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

    Day 90

Secondary Outcomes (3)

  • Proinflammatory cytokines

    Day 30

  • Adipokines

    Day 30

  • Proinflammatory cytokines

    Day 90

Study Arms (4)

Atorvastatin

EXPERIMENTAL

10mg of Atorvastatin

Drug: To compare monotherapies and combined therapy with each other

Fenofibrate

EXPERIMENTAL

267mg of Fenofibrate

Drug: To compare monotherapies and combined therapy with each other

Fenofibrate and atorvastatin

EXPERIMENTAL

10mg of Atorvastatin and 267mg of fenofibrate

Drug: To compare monotherapies and combined therapy with each other

Therapeutic Lifestyle Change

PLACEBO COMPARATOR

Placebo and Therapeutic Lifestyle Change

Drug: To compare monotherapies and combined therapy with each other

Interventions

To compare monotherapies and combined therapy with each otherDRUG

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

AtorvastatinFenofibrateFenofibrate and atorvastatinTherapeutic Lifestyle Change

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacology

Katowice, Silesian Voivodeship, 40-762, Poland

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Psychotherapy, Multiple

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 6, 2010

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

April 9, 2010

Record last verified: 2006-03

Locations

PL(1)