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Glycemic ControlNCT05617157

Effects of Stair Stepping on Late Day Postprandial Glycemia

A study testing Stair stepping in people with Glycemic Control, run by San Diego State University 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

1. Purpose/objective: The purpose of the current study is to investigate whether the benefits of stair stepping established for early day food consumption extend to late day food consumption. 2. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Glycemic Control
What is being tested?
Stair stepping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Dec 2022to 7 May 2024
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Generally healthy individuals able to stair step for 1 minute

Who cannot join

  • Prior to enrolling in the study, each potential participant will complete the Physical Activity Recall Questionnaire (PAR-Q+) to screen for cardiovascular risks. Any positive responses to questions from the PAR-Q+ will eliminate the individual from selection.
  • Participants who self report any condition that will prevent them form safely and/or comfortably climbing stairs will also be excluded form participation.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Diego State University

    San Diego, California, 92182

Other trials in United States

About this study

  1. Purpose/objective: The purpose of the current study is to investigate whether the benefits of stair stepping established for early day food consumption extend to late day food consumption.
  2. Methods: Participants will perform two standard oral glucose tolerance test (OGTT), consuming 75g of glucose dissolved in 350mL of water followed by assessment of glycemic markers for 2 hours. Participants will perform the OGTTs in the evening of two separate days. One day will be the control condition, where participants will remain seated throughout the entire duration of the OGTT. The other day (in randomized order) participants will perform 1 min of stair stepping at a self-selected, comfortable pace 28min after the consumption of the glucose solution. Blood glucose measurement via standard, over the counter finger sticks will be performed every 10 min for the first hour, and again at 90 and 120min of the OGTT. In addition, standard venipuncture blood draws (5mL) will be drawn at baseline ad at peak (30min) glucose excursion for the assessment of insulin. Participants will be instructed to not vary their diet or exercise during the two testing days. Diet and activity logs will be collected and analyzed to verify compliance.
  3. Subjects Adults 18 or over will be recruited for this project. Prior to enrolling in the study, each potential participant will complete the Physical Activity Recall Questionnaire (PAR-Q+) to screen for cardiovascular risks. Any positive responses to questions from the PAR-Q+ will eliminate the individual from selection. Participants who self report any condition that will prevent them form safely and/or comfortably climbing stairs will also be excluded form participation.
  4. Planned analyses: Results will be analyzed via a 2-factor repeated measure analysis of variance for time and condition. Statistical significance will be set at an alpha level of 0.05.
  5. Potential benefits: This study will help to identify the shortest possible bout of exercise that is still effective in significantly reducing postprandial blood glucose using a simple, cheap, and ubiquitously available exercise mode - stair stepping. In addition, participants will be informed of their fasting and postprandial glycemic response if they so desire. At the end of the study, individuals that want their test results will be given a copy. However, we cannot guarantee the subjects will benefit from this information.
  6. Potential risks:

Risks are comparable to regular everyday life. Stair stepping performed in this study presents the same risk of falling or errant stepping related injuries as any other stair stepping at a comfortable pace. Finger sticks and venipunctures present no greater risk than a regular routine physical examination. Whenever blood is drawn, there is a small risk of bruising or infection.

Being tested
Stair stepping

What participants receive

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

  • Stair steppingOther

    stepping up and down 32 stairs for 1 minute

Study groups in NCT05617157
Study groupRoleWhat they receive
ControlNo interventionNot described
Stair steppingExperimentalNot described
Receives: Other: Stair stepping

What is being measured

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

  1. Plasma Glucose

    Plasma Glucose

    Measured: 0-120 minutes after 75g of glucose consumption

Secondary outcomes (1)
  1. Insulin

    Insulin

    Measured: 0 and 60 minutes after 75g of glucose consumption

Timeline

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

  1. First posted15 Nov 2022
  2. Study start1 Dec 2022
  3. Primary completion31 Dec 2023
  4. Study completion7 May 2024

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05617157
Sponsor's protocol ID
HS-2022-0184
Status last verified
Aug 2024
First submitted
7 Nov 2022
Last updated
29 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Stair stepping in people with Glycemic Control, run by San Diego State University 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 1 inclusion and 2 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 29 Aug 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Plasma Glucose (time frame: 0-120 minutes after 75g of glucose consumption). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Aug 2024.

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