Trial Outcomes & Findings for Exercise, Statins, and the Metabolic Syndrome (NCT NCT01700530)

NCT ID: NCT01700530

Last Updated: 2016-02-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 121 participants
• Primary outcome timeframe: Change from Baseline to 12 weeks
• Results posted on: 2016-02-05

Participant Flow

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.

Participant milestones

Measure	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
Overall Study STARTED	9	21	20
Overall Study COMPLETED	9	18	19
Overall Study NOT COMPLETED	0	3	1

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	0	3	1

Baseline Characteristics

Exercise, Statins, and the Metabolic Syndrome

Baseline characteristics by cohort

Measure	Statin n=9 Participants Statins (40mg/day)for an average of 12 weeks Statin: Statins (40mg/day)for 12 weeks	Exercise Only n=21 Participants 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 n=20 Participants 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 n=50 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 10 • n=5 Participants	44 years STANDARD_DEVIATION 12 • n=7 Participants	43 years STANDARD_DEVIATION 9 • n=5 Participants	44 years STANDARD_DEVIATION 10 • n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	50 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	13 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	21 participants n=7 Participants	20 participants n=5 Participants	50 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 12 weeks

Population: Statins blocked exercise induced change in fitness

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

Outcome measures

Measure	Statin n=9 Participants Statins (40mg/day)for an average of 12 weeks Statin: Statins (40mg/day)for 12 weeks	Exercise Only n=18 Participants 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 n=19 Participants 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
% Change in VO2max (Fitness)	0 percentage change of VO2max Standard Deviation 6	10 percentage change of VO2max Standard Deviation 5	1.5 percentage change of VO2max Standard Deviation 6

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Measure	Statin n=9 Participants Statins (40mg/day)for an average of 12 weeks Statin: Statins (40mg/day)for 12 weeks	Exercise Only n=19 Participants 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 n=18 Participants 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
Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)	0 percent change Standard Error 10	13 percent change Standard Error 7	-4.5 percent change Standard Error 8

Adverse Events

Statins + Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Statin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John P. Thyfault, PhD

University of Missouri

Phone: 573-874-9728

Email: thyfaultj@missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place