Clinical Trials Directory

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

TypeNameDescription
DRUGStatinStatins (40mg/day)for 12 weeks
OTHERExercise only12 weeks of exercise training (5 days a week for 45-50 min a session)
OTHERStatins + ExerciseStatins (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.