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LIFESTAT - Living With Statins, a Cross Sectional Study

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ClinicalTrials.gov Identifier: NCT02250677
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Flemming Dela, University of Copenhagen

Brief Summary:

Background Statins are cholesterol lowering drugs that are prescribed to lower the risk of cardio-vascular diseases (CVD). The use of statins has increased markedly and it is now one of the most prescribed drugs in the world. 600,000 people in Denmark are taking statins on a daily basis, 40 % of these are taking the medication without having any other risk factors for CVD than elevated blood-cholesterol i.e. they are in primary prevention.

Statins are not without side effects and studies have shown that there is an elevated risk of developing diabetes when taking statins. This has led to an increased debate about the use of statins in primary prevention. Furthermore a large meta-analysis has shown that to prevent one event of CVD, it is necessary to treat 200 people for 3-5 years. These data suggest that more conservative use of statins to prevent CVD in otherwise healthy individuals at low risk for future CVD may be warranted.

Other side effects of statins are muscle myalgia, muscle cramps and fatigue which potentially can prevent a physically active lifestyle. The biomedical background of these side effects is not fully elucidated but it has been shown that there is a link to decreasing levels of an important enzyme, Q10, which plays a role in muscle energy metabolism.

Hypothesis

The overarching research question is: why does statin treatment cause muscle pain? Does statin treatment impair (or even prohibit) physical exercise training? Furthermore we would like to answer the following questions:

a Does statin treatment impair (or even prohibit) physical exercise training?

b Does statin treatment cause:

  • Decreased muscle strength?
  • Skeletal muscle inflammation?
  • Decreased mitochondrial respiratory function?

c Abnormal glucose homeostasis?


Condition or disease
Cardiovascular Disease Diabetes Mellitus

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: LIFESTAT - Living With Statins, a Cross Sectional Study on the Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being
Study Start Date : April 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with myalgia
Patients with myalgia as a side effect to treatment with Simvastatin (minimum 20 mg daily)
Patients without myalgia
Patients treated with Simvastatin (minimum 20 mg daily) without any side effects to the treatment
Control group
Patients with elevated serum cholesterol not treated with cholesterol lowering drugs



Primary Outcome Measures :
  1. Differences in physical performance between two groups of statin treated patients [ Time Frame: Three experimental days ]
    Differences in physical performance is measured by VO2-max and muscle strength


Biospecimen Retention:   Samples With DNA
Samples with plasma, muscle and fat biopsies are retained for analysis after enrolment of the last subject.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients will be recruited through advertisement in pharmacies and through newspapers. The patients will be recruited among statin users that are in primary prevention.
Criteria

Inclusion Criteria:

  • 40-70 years
  • BMI 25-35
  • Taking Simvastatin minimum 40 mg daily

Exclusion Criteria:

  • Diabetes Mellitus
  • Cardiovascular disease such as arrythmia, ischaemic heart disease
  • Mental disorders preventing the subject to understand the project description

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250677


Locations
Denmark
University of Copenhagen
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Flemming Dela, MD, MDSci University of Copenhagen

Publications:
Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvänne M, Scholte op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; European Association for Cardiovascular Prevention & Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012 Jul;33(13):1635-701. doi: 10.1093/eurheartj/ehs092. Epub 2012 May 3. Erratum in: Eur Heart J. 2012 Sep;33(17):2126.

Responsible Party: Flemming Dela, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02250677     History of Changes
Other Study ID Numbers: LIFESTAT - Cross Sectional
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Flemming Dela, University of Copenhagen:
physical activity
Statin therapy
cardiovascular disease
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents