Completed

Simvastatin's Impact on Exercise Training Adaptations in Metabolic Syndrome Patients

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Study Aim

This study aims to evaluate how Simvastatin affects the improvement in fitness, measured as % change in VO2max, after 12 weeks of treatment in individuals with metabolic syndrome who are undergoing exercise training.

What is being tested

Daily Statin Treatment

+ 12-Week Exercise Training

+ Statins and Exercise Program

DrugOther
Who is being recruted

Behavior+12

+ Body Weight

+ Hyperinsulinism

From 25 to 59 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2007
See protocol details

Summary

Principal SponsorUniversity of Kansas Medical Center
Last updated: February 5, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2007

Actual date on which the first participant was enrolled.

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).

NCT01700530
Principal SponsorUniversity of Kansas Medical Center
Last updated: February 5, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

121 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 59 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBody WeightHyperinsulinismInsulin ResistanceMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightObesityMetabolic SyndromeSedentary Behavior

Criteria

4 inclusion criteria required to participate
2 of 4 other characteristics of the metabolic syndrome including fasting glucose of 100 to 125 mg/dl; waist circumference greater than 102 cm in men and 88 cm in women, serum triglyceride concentration greater than 150 mg/dl, HDL-C concentrations less than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85 mmHG
Sedentary metabolic syndrome subjects will be 25-59 y of age
Women must be taking birth control or be postmenopausal
overweight to Class I or II obese (BMI 25-39 kg/m2) men and women
9 exclusion criteria prevent from participating
Diagnosed cardiovascular disease or diabetes or disease
Fasting blood glucose of greater than 126 mg/dl
Individuals exercising regularly (more than one 30 min session per week)
Individuals with an orthopedic limitations for walking
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Statins (40mg/day)for an average of 12 weeks

Group II

Experimental
12 weeks of exercise training (5 days a week for 45-50 min a session)

Group III

Active Comparator
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Missouri

Columbia, United StatesOpen University of Missouri in Google Maps
CompletedOne Study Center