Postprandial HyperglycemiaNCT04958317
Night Time Walking to Improve Glycaemic Control in Healthy Adults
A study testing Early exercise and Late exercise in people with Postprandial Hyperglycemia and Insulin Resistance, run by Monash University.
Trial summary
Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia, Insulin Resistance
- What is being tested?
- Early exercise and Late exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Oct 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and Women aged 18 to 65 years of age
- Waist circumference of <94cm and <80cm for Caucasian males and females, respectively
- Waist circumference of <90cm and <80 cm for Asian males and females, respectively
- Willingness to provide written informed consent and willingness to participate and comply with the study
Who cannot join
- Current or recent treatment (within 6 months) with medications that influence blood glucose
- Fasting blood glucose ≥ 7 mmol/L
- Individuals diagnosed with type 1 or type 2 diabetes mellitus, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac) or any other condition deemed unstable
- Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
- Not able to walk for 30 mins at 5-5.5 km/hr
- Women planning pregnancy, pregnant or lactating.
About this study
Official title: The Effect of Exercise Timing on Postprandial Glycaemic Control: a Randomised Crossover Trial in Healthy Adults
Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time.
Read the detailed description
In this crossover trial, eligible participants will be randomised to a 30-minute bout of physical activity (30 minute walk) either during the day or after an evening meal. The postprandial response to the evening meal will be analysed.
- Conditions
- Postprandial Hyperglycemia, Insulin Resistance
- Being tested
- Early exercise, Late exercise
- Keywords
- glucose tolerance, meal timing, insulin, postprandial, walking
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early exerciseOther
Participants will exercise for 30 minutes prior to an evening meal.
Late exerciseOther
Participants will exercise for 30 minutes after an evening meal.
| Study group | Role | What they receive |
|---|---|---|
| Early exercise | Placebo comparator | Participants will exercise for 30 minutes prior to an evening meal Receives: Other: Early exercise |
| Late exercise | Experimental | Participants will exercise for 30 minutes after an evening meal Receives: Other: Late exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
Change in glucose incremental area under the curve (iAUC) in response to a meal challenge
Measured: Three hour glucose iAUC will be calculated at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.
Secondary outcomes (1)
Postprandial insulin
Change in insulin incremental area under the curve (iAUC) in response to a meal challenge
Measured: Three hour insulin iAUC will be calculated at six time points (0, 30, 60, 90, 120 and 180 mins) after beginning consumption of the test meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study startDec 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Trial was planned for 2020, but Melbourne 2020 and 2021 lockdowns hindered the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara R. Cardoso, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958317
- Sponsor's protocol ID
- Night Glucose response-walk
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Timing on Postprandial Glycaemic Control: a Randomised Crossover Trial in Healthy Adults
- ClinicalTrials.gov ID
- NCT04958317
- Acronym / sponsor ID
- Night Glucose response-walk
- Conditions
- Postprandial Hyperglycemia, Insulin Resistance
- Keywords
- glucose tolerance, meal timing, insulin, postprandial, walking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was planned for 2020, but Melbourne 2020 and 2021 lockdowns hindered the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Jul 2021 (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.
Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time.
Detailed description
In this crossover trial, eligible participants will be randomised to a 30-minute bout of physical activity (30 minute walk) either during the day or after an evening meal. The postprandial response to the evening meal will be analysed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early exercise | Placebo comparator | Other: Early exerciseParticipants will exercise for 30 minutes prior to an evening meal |
| Late exercise | Experimental | Other: Late exerciseParticipants will exercise for 30 minutes after an evening meal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and Women aged 18 to 65 years of age
- Waist circumference of <94cm and <80cm for Caucasian males and females, respectively
- Waist circumference of <90cm and <80 cm for Asian males and females, respectively
- Willingness to provide written informed consent and willingness to participate and comply with the study
Key exclusion criteria (6 listed)
- Current or recent treatment (within 6 months) with medications that influence blood glucose
- Fasting blood glucose ≥ 7 mmol/L
- Individuals diagnosed with type 1 or type 2 diabetes mellitus, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac) or any other condition deemed unstable
- Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
- Not able to walk for 30 mins at 5-5.5 km/hr
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 |
|---|---|---|
| Early exerciseParticipants will exercise for 30 minutes prior to an evening meal. | Other | Early exercise |
| Late exerciseParticipants will exercise for 30 minutes after an evening meal. | Other | Late exercise |
Primary outcome
Postprandial glucose
Time frame: Three hour glucose iAUC will be calculated at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.
Change in glucose incremental area under the curve (iAUC) in response to a meal challenge
1 secondary outcome
Postprandial insulin
Time frame: Three hour insulin iAUC will be calculated at six time points (0, 30, 60, 90, 120 and 180 mins) after beginning consumption of the test meal.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Early exercise and Late exercise in people with Postprandial Hyperglycemia and Insulin Resistance, run by Monash University.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Postprandial glucose (time frame: Three hour glucose iAUC will be calculated at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.). 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 21 Nov 2024.