Exercise, Statins, and the Metabolic Syndrome - Full Text View

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 Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Exercise, Statins, and the Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Metabolic Syndrome Statins

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

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 ]
% 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 ]
% 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)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, Meers GM, Ruebel M, Laughlin MH, Dellsperger KC, Fadel PJ, Thyfault JP. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013 Aug 20;62(8):709-14. doi: 10.1016/j.jacc.2013.02.074. Epub 2013 Apr 10.


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

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 June 27, 2017