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Exercise, Statins, and the Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01700530
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Collaborators:
University of Missouri-Columbia
American Heart Association
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metabolic Syndrome
Obese
Sedentary
Interventions Drug: Statin
Other: Exercise only
Other: Statins + Exercise
Enrollment 121
Recruitment Details If meeting qualifications after initial phone screening, subject consented followed by another round of screening to determine if they had 2/5 risk factors or not which eliminated many subjects. Thus the difference between the 121 subjects reported for who signed consents and the 50 who entered the participant flow module.
Pre-assignment Details  
Arm/Group Title Statin Exercise Only Statins + Exercise
Hide Arm/Group Description

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

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

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

Exercise only: 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

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

Period Title: Overall Study
Started 9 21 20
Completed 9 18 19
Not Completed 0 3 1
Reason Not Completed
Withdrawal by Subject             0             3             1
Arm/Group Title Statin Exercise Only Statins + Exercise Total
Hide Arm/Group Description

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

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

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

Exercise only: 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

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

Total of all reporting groups
Overall Number of Baseline Participants 9 21 20 50
Hide Baseline Analysis Population Description
Sedentary, obese, 2/5 metabolic syndrome risk factors, males and females
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 21 participants 20 participants 50 participants
44  (10) 44  (12) 43  (9) 44  (10)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 21 participants 20 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
21
 100.0%
20
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 21 participants 20 participants 50 participants
Female
4
  44.4%
13
  61.9%
11
  55.0%
28
  56.0%
Male
5
  55.6%
8
  38.1%
9
  45.0%
22
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 21 participants 20 participants 50 participants
9 21 20 50
1.Primary Outcome
Title % Change in VO2max (Fitness)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Statins blocked exercise induced change in fitness
Arm/Group Title Statin Exercise Only Statins + Exercise
Hide Arm/Group Description:

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

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

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

Exercise only: 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

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

Overall Number of Participants Analyzed 9 18 19
Mean (Standard Deviation)
Unit of Measure: percentage change of VO2max
0  (6) 10  (5) 1.5  (6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Statin, Exercise Only, Statins + Exercise
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)
Hide Description % change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Statin Exercise Only Statins + Exercise
Hide Arm/Group Description:

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

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

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

Exercise only: 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

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

Overall Number of Participants Analyzed 9 19 18
Mean (Standard Error)
Unit of Measure: percent change
0  (10) 13  (7) -4.5  (8)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Statin Exercise Only Statins + Exercise
Hide Arm/Group Description

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

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

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

Exercise only: 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

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

All-Cause Mortality
Statin Exercise Only Statins + Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Statin Exercise Only Statins + Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/21 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Statin Exercise Only Statins + Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/21 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John P. Thyfault, PhD
Organization: University of Missouri
Phone: 573-874-9728
EMail: thyfaultj@missouri.edu
Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01700530    
Other Study ID Numbers: 09CRP2260136
First Submitted: September 26, 2012
First Posted: October 4, 2012
Results First Submitted: October 14, 2014
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016