- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115383
Effects of Exercise on the Renin-angiotensin System
The Effects of Exercise and Training Status on the Counter-regulatory Axis of the Renin-angiotensin-system.
Angiotensin converting enzyme-2 (ACE2) is part of the renin-angiotensin system (RAS), which is involved in maintaining blood flow and electrolyte balance. It has been shown in obese and hypertensive individuals that levels of another molecule Angiotensin converting enzyme (ACE) are much higher, leading to inflammation, fibrosis, vasoconstriction and high blood pressure. ACE2 has a protective effect from ACE, leading to anti-inflammatory, anti-fibrotic and vasodilating effects.
In animal models, it has been shown that aerobic exercise can increase levels of ACE2, while decreasing levels of ACE and offers protection to the cardiovascular system by keeping these two molecules balanced. Although the effects of exercise on the classical arm of the RAS have been studied significantly, ACE2 is a relatively new discovery and has not been studied as extensively in humans. The purpose of this research is to determine the effects of exercise training status on the RAS, specifically on ACE2 and its products.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The design of the proposed study is an intervention study, where participants are selected into either a physically active group or a sedentary group. The physically active group will be set as our control, as the physiological stress of the exercise protocol should be lower in the physically active group and limit the magnitude of the response. Both groups will be exposed to the same experimental procedure. Participants will be placed in their group based on their responses to the CSEP Get Active questionnaire. Individuals who do not accumulate less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group, while those who accumulate more than 150 minutes will be placed in the active group.
Participants will be asked to avoid anti-Inflammatory medications, drugs, alcohol and smoking 48 hours prior to any of the sessions.
Participants in both groups will undergo the same testing procedure. Tests will include densitometry and a graded exercise test to measure maximum VO2 and associated parameters. Venipuncture (10 ml) will be performed before, after and 30 minutes post VO2 max test. The proposed study analysis will be conducted using a dependent groups ANOVA and Tukey's post hoc testing.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A3K7
- Exercise Nutrition Laboratory, Western University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- between the ages of 18-39
- ability to exercise to exhaustion
- ability to give informed consent
Exclusion Criteria:
- chronic consumption of recreational drugs, tobacco or alcohol
- on any prescription medication or anti-inflammatory medications
- diagnosed with any chronic conditions
- current diagnosis with COVID-19
- BMI >30
- Engage in 75-150 minutes of moderate to vigorous physical activity a week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Sedentary Group
Individuals who are physically active for less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group.
|
The participant will be equipped with a vo2 mask or mouthpiece.
They will get on the bike and begin with a 5 minute warmup ranging from 30-100 watts.
After the warm up there will be a 15-30 watt increase every minute in the cadence that the participant is required to maintain.
Once the participant has decided to stop pedalling, the participants mask will be removed to ensure they are feeling well.
They will allowed to continue pedaling at their own pace for a cool down for up to two minutes.
|
ACTIVE_COMPARATOR: Active Group
Individuals who are physically active for greater than 150 minutes of moderate to vigorous physical activity will be placed in the active group.
|
The participant will be equipped with a vo2 mask or mouthpiece.
They will get on the bike and begin with a 5 minute warmup ranging from 30-100 watts.
After the warm up there will be a 15-30 watt increase every minute in the cadence that the participant is required to maintain.
Once the participant has decided to stop pedalling, the participants mask will be removed to ensure they are feeling well.
They will allowed to continue pedaling at their own pace for a cool down for up to two minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the mean response to an acute bout of physical activity in the components of the renin-angiotensin system
Time Frame: measurements will be taken before, immediately post and 30 minutes post exercise.
|
Measurements of Angiotensin(1-10) and Angiotensin(1-9) will be analyzed using ELISA kits.
|
measurements will be taken before, immediately post and 30 minutes post exercise.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the baseline measurements of the renin-angiotensin system between physically active and sedentary males.
Time Frame: Measurements will be made prior to commencement of exercise protocols.
|
Ratios of Angiotensin(1-10) and Angiotensin(1-9) will be compared between the two groups
|
Measurements will be made prior to commencement of exercise protocols.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 117957
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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