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

September 26, 2012
January 4, 2016
May 2007
May 2011   (final data collection date for primary outcome measure)
% 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
Fitness [ Time Frame: Baseline and after 12 weeks of treatment ] [ Designated as safety issue: No ]
% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max
Complete list of historical versions of study NCT01700530 on ClinicalTrials.gov Archive Site
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
  • Mitochondrial content in skeletal muscle [ Time Frame: Baseline and after 12 weeks of treatment ] [ Designated as safety issue: No ]
    % change in mitochondrial content between baseline and after 12 weeks of treatment will be assessed in muscle from biopsies
  • Metabolic Syndrome markers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Fasting glucose Plasma triglycerides and other blood lipids HDL-Cholesterol Waist Circumference Blood Pressure
  • Metabolic Syndrome Markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Fasting glucose Plasma triglycerides and other blood lipids HDL-Cholesterol Waist Circumference
Not Provided
Not Provided
 
Exercise, Statins, and the Metabolic Syndrome
Exercise, Statins, and the Metabolic Syndrome
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Obese
  • Sedentary
  • Drug: Statin
    Statins (40mg/day)for 12 weeks
    Other Name: simvastatin
  • Other: Exercise only
    12 weeks of exercise training (5 days a week for 45-50 min a session)
    Other Name: Physical activity
  • 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
  • Experimental: Statin
    Statins (40mg/day)for an average of 12 weeks
    Intervention: Drug: Statin
  • Experimental: Exercise only
    12 weeks of exercise training (5 days a week for 45-50 min a session)
    Intervention: Other: Exercise only
  • Active Comparator: Statins + Exercise
    Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
    Intervention: Other: Statins + Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
May 2011
May 2011   (final data collection date for primary outcome measure)

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)
Both
25 Years to 59 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01700530
09CRP2260136
No
Not Provided
Not Provided
University of Kansas Medical Center
University of Kansas Medical Center
  • University of Missouri-Columbia
  • American Heart Association
Principal Investigator: John P Thyfault, PhD University of Missouri-Columbia
University of Kansas Medical Center
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP