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| Name | Class |
|---|---|
| University of Missouri-Columbia | OTHER |
| American Heart Association | OTHER |
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Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk factors. We also examined if statins impacted exercise response for mitochondrial content in muscle or aerobic fitness.
OBJECTIVES: Determine if simvastatin impairs exercise training adaptations.
BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle changes, including exercise, to reduce cardiovascular disease risk in patients with the metabolic syndrome. Statin use has been linked to skeletal muscle myopathy and impaired mitochondrial function, but it is unclear whether statin use alters adaptations to exercise training.
METHODS: We examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. Sedentary overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according to National Cholesterol Education Panel Adult Treatment Panel III criteria) were randomized to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40 mg per day). The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin | Experimental | Statins (40mg/day)for an average of 12 weeks |
|
| Exercise only | Experimental | 12 weeks of exercise training (5 days a week for 45-50 min a session) |
|
| Statins + Exercise | Active Comparator | Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statin | Drug | Statins (40mg/day)for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| % Change in VO2max (Fitness) | % change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max | Change from Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity) | % change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Thyfault, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23583255 | Derived | Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10. |
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If meeting qualifications after initial phone screening, subject consented followed by another round of screening to determine if they had 2/5 risk factors or not which eliminated many subjects. Thus the difference between the 121 subjects reported for who signed consents and the 50 who entered the participant flow module.
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| ID | Title | Description |
|---|---|---|
| FG000 | Statin | Statins (40mg/day)for an average of 12 weeks Statin: Statins (40mg/day)for 12 weeks |
| FG001 | Exercise Only | 12 weeks of exercise training (5 days a week for 45-50 min a session) Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session) |
| FG002 | Statins + Exercise | Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Sedentary, obese, 2/5 metabolic syndrome risk factors, males and females
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| ID | Title | Description |
|---|---|---|
| BG000 | Statin | Statins (40mg/day)for an average of 12 weeks Statin: Statins (40mg/day)for 12 weeks |
| BG001 | Exercise Only | 12 weeks of exercise training (5 days a week for 45-50 min a session) Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % Change in VO2max (Fitness) | % change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max | Statins blocked exercise induced change in fitness | Posted | Mean | Standard Deviation | percentage change of VO2max | Change from Baseline to 12 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Statin | Statins (40mg/day)for an average of 12 weeks Statin: Statins (40mg/day)for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John P. Thyfault, PhD | University of Missouri | 573-874-9728 | thyfaultj@missouri.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D019821 | Simvastatin |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| Exercise only | Other | 12 weeks of exercise training (5 days a week for 45-50 min a session) |
|
|
| Statins + Exercise | Other | Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks |
|
|
| BG002 | Statins + Exercise | Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Statins + Exercise |
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks |
|
|
|
| Secondary | Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity) | % change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention | Posted | Mean | Standard Error | percent change | 12 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Exercise Only | 12 weeks of exercise training (5 days a week for 45-50 min a session) Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session) | 0 | 21 | 0 | 21 |
| EG002 | Statins + Exercise | Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks | 0 | 20 | 0 | 20 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |