Cardiovascular DiseasesPhase 4NCT03360916

Impact of Statin Therapy on Adaptations to Aerobic Exercise

A Phase 4 study testing Lipitor 20Mg Tablet, Lipitor 80Mg Tablet and Exercise Program in people with Cardiovascular Diseases, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise. Read more about this study

Who is it for?: Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases
What is being tested?: Lipitor 20Mg Tablet, Lipitor 80Mg Tablet and Exercise Program
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2018to 5 Jun 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Body Mass Index (BMI) between 25-43 kg^m2
Sedentary (less than 150 min of physical activity/week during last 6 months)
Weight stable (no more than 5% change in body weight the previous 3 months)
>5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension).
Stable doses of medications for 90 days
Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Who cannot join

Smoking
Use of statins in the last 6 months
Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)
Diagnosis of chronic diseases including CVD, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
History of abnormal bleeding problems
Currently taking (within the last 10 days) anti-platelet medication (Plavix), Warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications

Show all 10Show fewer

>2 fold upper normal limit (UNL) for alanine aminotransferase (ALT) or creatinine
Women who are pregnant or breastfeeding
Individuals with polymorphisms known to be associated with susceptibility for statin induced myopathies (tested at screening)
Currently enrolled in another research study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kansas Medical Center
Kansas City, Kansas, 66160

Other trials in United States

About this study

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

Read the detailed description

High cholesterol and cardiovascular disease (CVD) is currently prevented and treated with statin therapy. Statin use can cause muscle weakness, fatigue and/or pain, and these symptoms can increase with dose and duration of statin use. Statins may also change the ability to exercise.

This study is testing how different doses of a statin, Lipitor, affect muscle health and exercise. The doses that will be used in this study (20 mg/day or 80 mg/day) are typical for treating high cholesterol.

This study is expected to last about 14 weeks.

Conditions: Cardiovascular Diseases
Being tested: Lipitor 20Mg Tablet, Lipitor 80Mg Tablet, Placebo, Exercise Program
Keywords: high cholesterol, exercise, statins
Medical subject headings: Cardiovascular Diseases, Hypercholesterolemia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lipitor 20Mg TabletDrug
Also called Atorvastatin
One tablet by mouth every day for 12 weeks.
Lipitor 80Mg TabletDrug
Also called Atorvastatin
One tablet by mouth every day for 12 weeks.
PlaceboDrug
One matching placebo tablet by mouth every day for 12 weeks.
Exercise ProgramBehavioural
Exercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.

Study groups in NCT03360916
Study group	Role	What they receive
Placebo & Exercise Group	Placebo comparator	Participants randomized to this group will undergo placebo treatment and an aerobic exercise program. Receives: Drug: Placebo; Behavioral: Exercise Program
Low Statin & Exercise Group	Experimental	Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program. Receives: Drug: Lipitor 20Mg Tablet; Behavioral: Exercise Program
High Statin & Exercise Group	Experimental	Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program. Receives: Drug: Lipitor 80Mg Tablet; Behavioral: Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Mitochondrial Respiratory Function
Measured: Value at 3 months minus value at baseline

Secondary outcomes (1)

Change in VO2 Max
Measured: Value at 12 months minus value at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20185 Jun 2024

First posted4 Dec 2017
Study start1 Feb 2018
Primary completion5 Jun 2024
Study completion5 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360916
Sponsor's protocol ID: STUDY00140791
Other IDs: R01AR071263
Status last verified: Apr 2025
First submitted: 20 Nov 2017
Last updated: 15 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Statin Therapy on Adaptations to Aerobic Exercise
ClinicalTrials.gov ID: NCT03360916
Acronym / sponsor ID: STUDY00140791
Conditions: Cardiovascular Diseases
Keywords: high cholesterol, exercise, statins
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: University of Kansas Medical CenterUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: 1 Feb 2018 (actual)
Primary completion: 5 Jun 2024 (actual)
Study completion: 5 Jun 2024 (actual)
First posted: 4 Dec 2017 (actual)
Results: Posted 15 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine how different doses of a statin affect muscle health and exercise.

Detailed description

This study is expected to last about 14 weeks.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo & Exercise Group	Placebo comparator	Drug: Placebo, Behavioral: Exercise ProgramParticipants randomized to this group will undergo placebo treatment and an aerobic exercise program.
Low Statin & Exercise Group	Experimental	Drug: Lipitor 20Mg Tablet, Behavioral: Exercise ProgramParticipants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
High Statin & Exercise Group	Experimental	Drug: Lipitor 80Mg Tablet, Behavioral: Exercise ProgramParticipants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Body Mass Index (BMI) between 25-43 kg^m2
Sedentary (less than 150 min of physical activity/week during last 6 months)
Weight stable (no more than 5% change in body weight the previous 3 months)
Stable doses of medications for 90 days
Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Key exclusion criteria (10 listed)

Smoking
Use of statins in the last 6 months
Use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil)
Diagnosis of chronic diseases including CVD, diabetes, other metabolic diseases (e.g., thyroid), cancer, HIV, or acquired immunodeficiency syndrome
History of abnormal bleeding problems

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lipitor 20Mg TabletAlso: AtorvastatinOne tablet by mouth every day for 12 weeks.	Drug	Low Statin & Exercise Group
Lipitor 80Mg TabletAlso: AtorvastatinOne tablet by mouth every day for 12 weeks.	Drug	High Statin & Exercise Group
PlaceboOne matching placebo tablet by mouth every day for 12 weeks.	Drug	Placebo & Exercise Group
Exercise ProgramExercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.	Behavioural	High Statin & Exercise Group, Low Statin & Exercise Group, Placebo & Exercise Group

Primary outcome

Difference in Mitochondrial Respiratory Function
Time frame: Value at 3 months minus value at baseline

1 secondary outcome

Change in VO2 Max
Time frame: Value at 12 months minus value at baseline

Results and safety

Results posted to the registry on 15 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	16	14
Low Dose Statin	17	13
High Dose Statin	19	16

Primary outcome: Difference in Mitochondrial Respiratory Function

Time frame: Value at 3 months minus value at baseline. Mean (Standard Deviation). Unit: pmols/s/mg

Measure	Placebo n = 11	Low Dose Statin n = 10	High Dose Statin n = 14
Value	2.29 (125.59)	-11.24 (130.12)	44.88 (105.19)

Placebo: Mean Difference (Net): 2.29, p = 0.9530, t-test, 2 sided
Low Dose Statin: Mean Difference (Net): -11.24, p = 0.7908, t-test, 2 sided
High Dose Statin: Mean Difference (Net): 44.88, p = 0.1344, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16
Low Dose Statin	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
High Dose Statin	0 of 19 (0%)	8 of 19 (42.1%)	0 of 19

Limitations and caveats (from the sponsor): The COVID-19 epidemic started in the middle of the trial forcing us to stop recruitment for four months. Furthermore, the continuation of the pandemic slowed recruitment for the rest of the trial and significantly impacted n size. There was also a national dextrose shortage following a hurricane in Puerto Rico. As a result many of the IVGTT were not conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Thyfault, PhD principal investigator

University of Kansas Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lipitor 20Mg Tablet, Lipitor 80Mg Tablet and Exercise Program in people with Cardiovascular Diseases, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Mitochondrial Respiratory Function (time frame: Value at 3 months minus value at baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.