NCT05115383

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

October 3, 2021

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the mean response to an acute bout of physical activity in the components of the renin-angiotensin system

    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 Outcomes (1)

  • Changes in the baseline measurements of the renin-angiotensin system between physically active and sedentary males.

    Measurements will be made prior to commencement of exercise protocols.

Study Arms (2)

Sedentary Group

ACTIVE COMPARATOR

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.

Other: VO2 Max test

Active Group

ACTIVE COMPARATOR

Individuals who are physically active for greater than 150 minutes of moderate to vigorous physical activity will be placed in the active group.

Other: VO2 Max test

Interventions

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 GroupSedentary Group

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between the ages of 18-39
  • ability to exercise to exhaustion
  • ability to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory, Western University

London, Ontario, N6A3K7, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2021

First Posted

November 10, 2021

Study Start

July 8, 2022

Primary Completion

December 31, 2022

Study Completion

April 30, 2023

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations