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
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.
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|
|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|
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
Patients with elevated serum cholesterol not treated with cholesterol lowering drugs
- 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
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
|University of Copenhagen|
|Copenhagen, Denmark, 2200|
|Principal Investigator:||Flemming Dela, MD, MDSci||University of Copenhagen|