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Exercise, Statins, and the Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01700530
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Collaborators:
University of Missouri-Columbia
American Heart Association
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obese Sedentary Drug: Statin Other: Exercise only Other: Statins + Exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise, Statins, and the Metabolic Syndrome
Study Start Date : May 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. % 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700530


Locations
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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
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Principal Investigator: John P Thyfault, PhD University of Missouri-Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01700530    
Other Study ID Numbers: 09CRP2260136
First Posted: October 4, 2012    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016
Last Verified: January 2016
Keywords provided by University of Kansas Medical Center:
mitochondria
fitness
statins
cholesterol
metabolic syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
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