Exercise, Statins, and the Metabolic Syndrome

January 4, 2016 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sedentary metabolic syndrome subjects will be 25-59 y of age
  • overweight to Class I or II obese (BMI 25-39 kg/m2) men and women
  • 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
  • Women must be taking birth control or be postmenopausal.

Exclusion Criteria:

  • Diagnosed cardiovascular disease or diabetes or disease
  • Symptoms that could alter their ability to perform exercise
  • Fasting blood glucose of greater than 126 mg/dl
  • Smoking
  • Taking any medications or supplements (e.g., statins, fibrates, metformin, thiazolidenediones, anti-hypertensives (ACE-inhibitors and angiotensin blockers) which could affect blood lipids or insulin sensitivity.
  • Women who are pregnant or plan to become pregnant during the duration of the study
  • Individuals exercising regularly (more than one 30 min session per week)
  • Individuals with an orthopedic limitations for walking.
  • Report any allergies to the medications (statins, lidocaine)

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Statin
Statins (40mg/day)for an average of 12 weeks
Drug: Statin
Statins (40mg/day)for 12 weeks
Other Names:
  • simvastatin
Experimental: Exercise only
12 weeks of exercise training (5 days a week for 45-50 min a session)
Other: Exercise only
12 weeks of exercise training (5 days a week for 45-50 min a session)
Other Names:
  • Physical activity
Active Comparator: Statins + Exercise
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Other: Statins + Exercise
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
Other Names:
  • Statins + Physical Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Change in VO2max (Fitness)
Time Frame: Change from Baseline to 12 weeks
% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max
Change from Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)
Time Frame: 12 weeks
% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

University of Missouri-Columbia
American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09CRP2260136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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