Exercise, Statins, and the Metabolic Syndrome

University of Kansas Medical Center121 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

121

Conditions

Metabolic Syndrome Obese Sedentary

Interventions

StatinDRUG

Statins (40mg/day)for 12 weeks

Exercise onlyOTHER

12 weeks of exercise training (5 days a week for 45-50 min a session)

Statins + ExerciseOTHER

Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks

Eligibility

Sex: ALLMin age: 25 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Missouri

Columbia, Missouri, United States

Outcomes

Primary Outcomes

% Change in VO2max (Fitness)

% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max

Time frame: Change from Baseline to 12 weeks

Secondary Outcomes

Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)

% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention

Time frame: 12 weeks

Data from ClinicalTrials.gov

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