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Trial record 59 of 93 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

Impact of Statin Therapy on Adaptations to Aerobic Exercise

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ClinicalTrials.gov Identifier: NCT03360916
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Lipitor 20Mg Tablet Drug: Lipitor 80Mg Tablet Drug: Placebo Behavioral: Exercise Program Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Statin Therapy on Adaptations to Aerobic Exercise
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo & Exercise Group
Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.
Drug: Placebo
One matching placebo tablet by mouth every day for 12 weeks.

Behavioral: Exercise Program
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.

Experimental: Low Statin & Exercise Group
Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.
Drug: Lipitor 20Mg Tablet
One tablet by mouth every day for 12 weeks.
Other Name: Atorvastatin

Behavioral: Exercise Program
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.

Experimental: High Statin & Exercise Group
Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.
Drug: Lipitor 80Mg Tablet
One tablet by mouth every day for 12 weeks.
Other Name: Atorvastatin

Behavioral: Exercise Program
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.




Primary Outcome Measures :
  1. Oxygen Consumption [ Time Frame: Change from Baseline to Week 12 ]
    Changes in cardiorespiratory fitness measured by oxygen consumption during increased exercise on a motorized treadmill and during lower intensity exercise sessions. Oxygen consumption will be measured at peak and at various time points to determine fitness.


Secondary Outcome Measures :
  1. Mitochondrial respiratory function [ Time Frame: Change from Baseline to Week 12 ]
    Mitochondrial respiration will be measured by commercially available O2k Oroboros device.

  2. Insulin sensitivity [ Time Frame: Change from Baseline to Week 12 ]
    Insulin sensitivity will be measured by a standardized intravenous glucose tolerance test (IVGTT) in which glucose and insulin responses are monitored following glucose infusion.

  3. Citrate synthase activity [ Time Frame: Change from Baseline to Week 12 ]
    This will be measured by an enzyme activity assay.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 25-43 kg^m2
  • Sedentary (less than 30 min of physical activity/week during last 6 months and less than 7,500 steps/day measures by pedometer at baseline)
  • 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
  • Stable doses of medications for 90 days
  • Willing to stop all Nonsteroidal Antiinflammatory Drugs (NSAIDs) and aspirin for 7 days prior to muscle biopsy

Exclusion Criteria:

  • 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 cardiovascular (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
  • >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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360916


Contacts
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Contact: Clara Amat, MS 913-945-8834 camatfernandez@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: John Thyfault, PhD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03360916     History of Changes
Other Study ID Numbers: STUDY00140791
R01AR071263 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Kansas Medical Center:
high cholesterol
exercise
statins
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors