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Exercise, Statins, and the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Obese, Sedentary

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Statin
Exercise only
Statins + Exercise
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring mitochondria, fitness, statins, cholesterol, metabolic syndrome

Eligibility Criteria

25 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Statin

Exercise only

Statins + Exercise

Arm Description

Statins (40mg/day)for an average of 12 weeks

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

Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks

Outcomes

Primary Outcome Measures

% Change in VO2max (Fitness)
% 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)
% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention

Full Information

First Posted
September 26, 2012
Last Updated
January 4, 2016
Sponsor
University of Kansas Medical Center
Collaborators
University of Missouri-Columbia, American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01700530
Brief Title
Exercise, Statins, and the Metabolic Syndrome
Official Title
Exercise, Statins, and the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
University of Missouri-Columbia, American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obese, Sedentary
Keywords
mitochondria, fitness, statins, cholesterol, metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Statin
Arm Type
Experimental
Arm Description
Statins (40mg/day)for an average of 12 weeks
Arm Title
Exercise only
Arm Type
Experimental
Arm Description
12 weeks of exercise training (5 days a week for 45-50 min a session)
Arm Title
Statins + Exercise
Arm Type
Active Comparator
Arm Description
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Statin
Other Intervention Name(s)
simvastatin
Intervention Description
Statins (40mg/day)for 12 weeks
Intervention Type
Other
Intervention Name(s)
Exercise only
Other Intervention Name(s)
Physical activity
Intervention Description
12 weeks of exercise training (5 days a week for 45-50 min a session)
Intervention Type
Other
Intervention Name(s)
Statins + Exercise
Other Intervention Name(s)
Statins + Physical Activity
Intervention Description
Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
Primary Outcome Measure Information:
Title
% Change in VO2max (Fitness)
Description
% 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 Outcome Measure Information:
Title
Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)
Description
% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Thyfault, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23583255
Citation
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.
Results Reference
derived

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Exercise, Statins, and the Metabolic Syndrome

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