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.
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
About this study
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Glycemic Control
- 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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Stair stepping | Experimental | Not described Receives: Other: Stair stepping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose
Plasma Glucose
Measured: 0-120 minutes after 75g of glucose consumption
Secondary outcomes (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.
- First posted15 Nov 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2023
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ControlStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Kressler, San Diego State University
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stair Stepping on Late Day Postprandial Glycemia
- ClinicalTrials.gov ID
- NCT05617157
- Acronym / sponsor ID
- HS-2022-0184
- Conditions
- Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Stair stepping | Experimental | Other: Stair stepping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy individuals able to stair step for 1 minute
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Stair steppingstepping up and down 32 stairs for 1 minute | Other | Stair stepping |
Primary outcome
Plasma Glucose
Time frame: 0-120 minutes after 75g of glucose consumption
Plasma Glucose
1 secondary outcome
Insulin
Time frame: 0 and 60 minutes after 75g of glucose consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.