Trial Outcomes & Findings for Impact of Statin Therapy on Adaptations to Aerobic Exercise (NCT NCT03360916)

NCT ID: NCT03360916

Last Updated: 2025-04-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: Value at 3 months minus value at baseline
• Results posted on: 2025-04-15

Participant Flow

All 52 participants that were officially enrolled were randomized

Participant milestones

Measure	Placebo Participants receiving matching placebo oral tablet. Placebo Oral Tablet: Matching placebo pill.	Low Dose Statin Participants will receive Lipitor 20Mg Tablet to take daily. Lipitor 20Mg Tablet: 20 mg/day pills.	High Dose Statin Participants will receive Lipitor 80Mg Tablet to take daily. Lipitor 80Mg Tablet: 80 mg/day pills.
Overall Study STARTED	16	17	19
Overall Study COMPLETED	14	13	16
Overall Study NOT COMPLETED	2	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Statin Therapy on Adaptations to Aerobic Exercise

Baseline characteristics by cohort

Measure	Placebo n=16 Participants Participants receiving matching placebo oral tablet. Placebo Oral Tablet: Matching placebo pill.	Low Dose Statin n=17 Participants Participants receiving Lipitor 20Mg Tablet to take daily. Lipitor 20Mg Tablet: 20 mg/day pills.	High Dose Statin n=19 Participants Participants receiving Lipitor 80Mg Tablet to take daily. Lipitor 80Mg Tablet: 80 mg/day pills.	Total n=52 Participants Total of all reporting groups
Age, Continuous	50.13 years STANDARD_DEVIATION 8.29 • n=5 Participants	51.28 years STANDARD_DEVIATION 9.04 • n=7 Participants	50.85 years STANDARD_DEVIATION 7.96 • n=5 Participants	50.78 years STANDARD_DEVIATION 8.28 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	40 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	19 participants n=5 Participants	52 participants n=4 Participants
Total Cholesterol	200.19 mg/dL STANDARD_DEVIATION 31.63 • n=5 Participants	220.33 mg/dL STANDARD_DEVIATION 38.54 • n=7 Participants	204.90 mg/dL STANDARD_DEVIATION 32.24 • n=5 Participants	208.65 mg/dL STANDARD_DEVIATION 34.72 • n=4 Participants
Weight	94.74 kg STANDARD_DEVIATION 16.15 • n=5 Participants	103.42 kg STANDARD_DEVIATION 20.06 • n=7 Participants	95.83 kg STANDARD_DEVIATION 14.33 • n=5 Participants	98.10 kg STANDARD_DEVIATION 17.08 • n=4 Participants
BMI	34.68 kg/m^2 STANDARD_DEVIATION 4.58 • n=5 Participants	35.43 kg/m^2 STANDARD_DEVIATION 5.14 • n=7 Participants	34.55 kg/m^2 STANDARD_DEVIATION 4.84 • n=5 Participants	34.88 kg/m^2 STANDARD_DEVIATION 4.79 • n=4 Participants
Relative Peak VO2 Max	25.29 mL/kg/min STANDARD_DEVIATION 6.21 • n=5 Participants	21.30 mL/kg/min STANDARD_DEVIATION 6.27 • n=7 Participants	22.74 mL/kg/min STANDARD_DEVIATION 5.74 • n=5 Participants	22.97 mL/kg/min STANDARD_DEVIATION 6.15 • n=4 Participants

PRIMARY outcome

Timeframe: Value at 3 months minus value at baseline

Outcome measures

Measure	Placebo n=11 Participants Participants receiving matching placebo oral tablet. Placebo Oral Tablet: Matching placebo pill.	Low Dose Statin n=10 Participants Participants receiving Lipitor 20Mg Tablet to take daily. Lipitor 20Mg Tablet: 20 mg/day pills.	High Dose Statin n=14 Participants Participants receiving Lipitor 80Mg Tablet to take daily. Lipitor 80Mg Tablet: 80 mg/day pills.
Difference in Mitochondrial Respiratory Function	2.29 pmols/s/mg Standard Deviation 125.59	-11.24 pmols/s/mg Standard Deviation 130.12	44.88 pmols/s/mg Standard Deviation 105.19

SECONDARY outcome

Timeframe: Value at 12 months minus value at baseline

Outcome measures

Measure	Placebo n=14 Participants Participants receiving matching placebo oral tablet. Placebo Oral Tablet: Matching placebo pill.	Low Dose Statin n=13 Participants Participants receiving Lipitor 20Mg Tablet to take daily. Lipitor 20Mg Tablet: 20 mg/day pills.	High Dose Statin n=16 Participants Participants receiving Lipitor 80Mg Tablet to take daily. Lipitor 80Mg Tablet: 80 mg/day pills.
Change in VO2 Max	0.22 L/min Standard Deviation 0.18	0.23 L/min Standard Deviation 0.21	0.21 L/min Standard Deviation 0.23

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Low Dose Statin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

High Dose Statin

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=16 participants at risk Participants receiving matching placebo oral tablet. Placebo Oral Tablet: Matching placebo pill.	Low Dose Statin n=17 participants at risk Participants receiving Lipitor 20Mg Tablet to take daily. Lipitor 20Mg Tablet: 20 mg/day pills.	High Dose Statin n=19 participants at risk Participants receiving Lipitor 80Mg Tablet to take daily. Lipitor 80Mg Tablet: 80 mg/day pills.
Musculoskeletal and connective tissue disorders Muscle or Joint Pain	12.5% 2/16 • Number of events 2 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.	23.5% 4/17 • Number of events 4 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.	36.8% 7/19 • Number of events 7 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
Musculoskeletal and connective tissue disorders Restless Legs	6.2% 1/16 • Number of events 1 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.	5.9% 1/17 • Number of events 1 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.	0.00% 0/19 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
Respiratory, thoracic and mediastinal disorders Respiratory Illness	0.00% 0/16 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.	0.00% 0/17 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.	10.5% 2/19 • Number of events 2 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.

Additional Information

John P. Thyfault

University of Kansas Medical Center

Phone: 913-588-1790

Email: jthyfault@kumc.edu

Results disclosure agreements

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