Exercise, Statins, and the Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborators:
University of Missouri-Columbia
American Heart Association
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01700530
First received: September 26, 2012
Last updated: January 4, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Metabolic Syndrome
Obese
Sedentary
Drug: Statin
Other: Exercise only
Other: Statins + Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise, Statins, and the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • % Change in VO2max (Fitness) [ Time Frame: Change from Baseline to 12 weeks ] [ Designated as safety issue: No ]
    % change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max


Secondary Outcome Measures:
  • Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    % change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention


Enrollment: 121
Study Start Date: May 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Statin
Statins (40mg/day)for an average of 12 weeks
Drug: Statin
Statins (40mg/day)for 12 weeks
Other Name: 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 Name: 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 Name: Statins + Physical Activity

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).

  Eligibility

Ages Eligible for Study:   25 Years to 59 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01700530

Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Kansas Medical Center
University of Missouri-Columbia
American Heart Association
Investigators
Principal Investigator: John P Thyfault, PhD University of Missouri-Columbia
  More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01700530     History of Changes
Other Study ID Numbers: 09CRP2260136 
Study First Received: September 26, 2012
Results First Received: October 14, 2014
Last Updated: January 4, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
mitochondria
fitness
statins
cholesterol
metabolic syndrome

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 29, 2016