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Exercise, Statins, and the Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborators:
University of Missouri-Columbia
American Heart Association
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01700530
First received: September 26, 2012
Last updated: January 4, 2016
Last verified: January 2016
Results First Received: October 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metabolic Syndrome
Obese
Sedentary
Interventions: Drug: Statin
Other: Exercise only
Other: Statins + Exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Statin

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

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

Exercise Only

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 + Exercise

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


Participant Flow:   Overall Study
    Statin     Exercise Only     Statins + Exercise  
STARTED     9     21     20  
COMPLETED     9     18     19  
NOT COMPLETED     0     3     1  
Withdrawal by Subject                 0                 3                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Sedentary, obese, 2/5 metabolic syndrome risk factors, males and females

Reporting Groups
  Description
Statin

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

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

Exercise Only

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 + Exercise

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 Total of all reporting groups

Baseline Measures
    Statin     Exercise Only     Statins + Exercise     Total  
Number of Participants  
[units: participants]
  9     21     20     50  
Age  
[units: years]
Mean (Standard Deviation)
  44  (10)     44  (12)     43  (9)     44  (10)  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     9     21     20     50  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     4     13     11     28  
Male     5     8     9     22  
Region of Enrollment  
[units: participants]
       
United States     9     21     20     50  



  Outcome Measures
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1.  Primary:   % Change in VO2max (Fitness)   [ Time Frame: Change from Baseline to 12 weeks ]

2.  Secondary:   Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: John P. Thyfault, PhD
Organization: University of Missouri
phone: 573-874-9728
e-mail: thyfaultj@missouri.edu



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
Health Authority: United States: Institutional Review Board