Living With Statins - Interventional Exercise Study (LIFESTAT)
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|ClinicalTrials.gov Identifier: NCT02796378|
Recruitment Status : Unknown
Verified January 2017 by Flemming Dela, University of Copenhagen.
Recruitment status was: Recruiting
First Posted : June 10, 2016
Last Update Posted : January 4, 2017
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. More than 600,000 people in Denmark are taking statins on a daily basis, approximately 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.
The overarching research question is: why does statin treatment cause muscle pain? Does statin treatment impair (or even prohibit) physical exercise training? Furthermore the following questions will be investigated:
A. Does statin treatment cause:
- Decreased muscle strength?
- Skeletal muscle inflammation?
- Decreased mitochondrial respiratory function? B. Abnormal glucose homeostasis?
Re question A & B: If so, can physical training counteract this effect of statin treatment?
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Diabetes Mellitus||Drug: Training+Simvastatin+Q10-placebo Drug: Training+Simvastatin-placebo+Q10-placebo Drug: Training+Simvastatin+Q10||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Training+Simvastatin+Q10-placebo
Training+Simvastatin+Q10-placebo. 8 Weeks of exercise training on a bicycle ergometer three times a week and 40 mg of Simvastatin pr day and Q10-placebo.
8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin 40 mg/day and Q10-placebo.
Other Name: Simvastatin KRKA
Placebo Comparator: Training+Simvastatin-placebo+Q10-placebo
Training+Simvastatin-placebo+Q10-placebo. 8 Weeks of exercise training on a bicycle ergometer three times a week, Simvastatin-placebo and Q10-placebo.
8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin-placebo and Q10-placebo.
Active Comparator: Training+Simvastatin+Q10
Training+Simvastatin+Q10. 8 Weeks of exercise training on a bicycle ergometer three times a week and 40 mg of Simvastatin pr day in combination with 400 mg of oral supplementation with Q10.
8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin 40 mg/day and Q10 400 mg/day.
- Physical performance measured by VO2-max [ Time Frame: 8 weeks ]Difference in physical performance measured by VO2-max (mlO2/min/kgBW) in the three different intervention groups.
- Myalgia measured by VAS [ Time Frame: 8 weeks ]Difference in potential myalgia, measured by visual analog scale (VAS) between the three different intervention groups.
- Difference in muscle strength measured by KinCom dynamometer and PowerRig [ Time Frame: 8 weeks ]Difference in muscle strength between the three different intervention groups.
- Difference in glucose metabolism measured by hyperinsulinemic euglycemic clamp [ Time Frame: 8 weeks ]Difference in glucose metabolism between the three different intervention groups.
- Difference in mitochondrial function measured by respirometry [ Time Frame: 8 weeks ]Difference in mitochondrial function between the three different intervention groups.
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): NCT02796378
|Contact: Flemming Dela, MD, MDSciemail@example.com|
|University of Copenhagen||Recruiting|
|Copenhagen, Denmark, 2200|
|Contact: Anja B Kuhlman, MD firstname.lastname@example.org|
|Principal Investigator: Flemming Dela, MD, DMSci|
|Principal Investigator:||Flemming Dela, MD, MDSci||University of Copenhagen|