Exercise, Statins, and the Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Exercise, Statins, and the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700530
• Other study ID #: 09CRP2260136
• Status: Completed
• Phase: N/A
• First received: September 26, 2012
• Last updated: January 4, 2016
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: January 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 59 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obese
• Sedentary
• Syndrome

Intervention

Drug:
• Statin
Statins (40mg/day)for 12 weeks

Other:
• Exercise only
12 weeks of exercise training (5 days a week for 45-50 min a session)
• Statins + Exercise
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Heart Association, University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Change in VO2max (Fitness)	% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max	Change from Baseline to 12 weeks	No
Secondary	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	12 weeks	No