Trials / Completed
CompletedNCT01700530
Exercise, Statins, and the Metabolic Syndrome
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- All
- Age
- 25 Years – 59 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Statin | Statins (40mg/day)for 12 weeks |
| OTHER | Exercise only | 12 weeks of exercise training (5 days a week for 45-50 min a session) |
| OTHER | Statins + Exercise | Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2012-10-04
- Last updated
- 2016-02-05
- Results posted
- 2016-02-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01700530. Inclusion in this directory is not an endorsement.