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Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being (LIFESTAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255682
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : January 4, 2017
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. 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 cardio-vascular diseases 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 cardio-vascular disease, 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 prevent) physical exercise training? Furthermore we would like to answer the following questions:

  1. Does statin treatment impair (or even prohibit) physical exercise training?
  2. Does statin treatment cause:

    • Decreased muscle strength?
    • Skeletal muscle inflammation?
    • Decreased mitochondrial respiratory function?
  3. Abnormal glucose homeostasis?

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diabetes Mellitus Drug: Simvastatin Dietary Supplement: Q10 Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being
Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Placebo Comparator: Simvastatin and Q10-placebo
Simvastatin 40 mg orally administered daily and Q10-placebo for 8 weeks
Drug: Simvastatin
Other Names:
  • Simvastatin Actavis
  • Simvastatin Hexal
  • Simvastatin KRKA
  • Simvastatin Orion
  • Simvastatin Sandoz
  • Simvastatin Stada
  • Simvastatin Teva
  • Zocor

Active Comparator: Simvastatin and Q10
Simvastatin 40 mg orally administered daily for 8 weeks in combination with Q10 supplementation of 400 mg/daily
Drug: Simvastatin
Other Names:
  • Simvastatin Actavis
  • Simvastatin Hexal
  • Simvastatin KRKA
  • Simvastatin Orion
  • Simvastatin Sandoz
  • Simvastatin Stada
  • Simvastatin Teva
  • Zocor

Dietary Supplement: Q10
Other Name: Bioquinon Q10




Primary Outcome Measures :
  1. Difference in myalgia [ Time Frame: 8 weeks ]
    Difference in myalgia, measured by visual analog scale (VAS) between Simvastatin treated patients receiving Q10 or Q10-placebo.


Secondary Outcome Measures :
  1. Difference in VO2-max [ Time Frame: 8 weeks ]
    Difference in VO2-max in Simvastatin treated patients receiving Q10 or Q10-placebo.

  2. Difference in muscle strength [ Time Frame: 8 weeks ]
    Difference in muscle strength in Simvastatin treated patients receiving Q10 or Q10-placebo.

  3. Difference in glucose metabolism [ Time Frame: 8 weeks ]
    Difference in glucose metabolism in Simvastatin treated patients receiving Q10 or Q10-placebo.

  4. Difference in mitochondrial function [ Time Frame: 8 weeks ]
    Difference in mitochondrial function in Simvastatin treated patients receiving Q10 or Q10-placebo.



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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
Criteria

Inclusion Criteria:

  • 40-70 years.
  • BMI 25-35.
  • prescribed Simvastatin 40 mg/daily by their general practitioner.

Exclusion Criteria:

  • Diabetes Mellitus.
  • Cardiovascular disease such as arrythmia, ischaemic heart disease.
  • Musculoskeletal disorders preventing the subject to perform physical.
  • 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): NCT02255682


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Flemming Dela, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02255682    
Other Study ID Numbers: LIFESTAT - Observational Study
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Flemming Dela, University of Copenhagen:
physical activity
statin therapy
diabetes mellitus
cardiovascular disease
Q10-supplementation
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors