Testing High-intensity interval training for prediabetic state
Official title: Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors
- 2 groups
- One site, in Sherbrooke
- Recruiting
Interventions
- Behavioural therapy
High-intensity interval training
3 times per week high-intensity interval training (HIIT) on a cycle ergometer for 12 weeks.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Centre de recherche du CHUS
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Fasting plasma glucose: 6.1 to 6.9 mmol/L or
- +2-hour plasma glucose post 75g OGTT: 7.8 to 11.0 mmol/L and
- +HbA1c: 6.0 to 6.4%
- +Pre-diabetes:
- +or Insulin resistant: glucose clearance rate ≤ 360 ml/kg/min as determined using the Oral Glucose Insulin Sensitivity Index at Time 120 min.
- +BMI \> 25 kg/m2
- +To be willing and able to adhere to the specifications of the protocolProtocolThe detailed plan a study must follow.Read more →;
- +To have signed an informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → document indicating that they understood the purpose of and procedures required for the study and were willing to participate in the study.
Exclusion
- −overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG
- −Treatment with any drug known to affect lipid or carbohydrate metabolism, except statins (to be stopped 3 weeks prior to study A), metformin or anti-hypertensive drugs (to be stopped 7 days prior to the studies);
- −presence of liver or renal disease other than uncomplicated NASH or mild isolated proteinuria; uncontrolled thyroid disorder;
- −Uncontrolled severe hypertension, systolic pressure ≥ 180 mm Hg or diastolic pressure ≥ 110 mm Hg;
- −History of ischemic heart disease, tachyarrhythmia, QT interval prolongation, risk factors for torsade de pointes (eg hypokalemia), or taking any medication known to prolong the QT interval;
- −Presence of a pacemaker;
- −Having undergone a PET study or CT scan in the past year;
- −Any contraindication to stopping statins for 3 months and stopping an anti-hypertensive medication and metformin for 7 days;
- −No blood donation two month prior the study;
- −prior history or current fasting plasma cholesterol level \> 7 mmol/l or fasting TG \> 6 mmol/l.
- −History of serious gastrointestinal disorders (malabsorption, peptic ulcer, gastroesophageal reflux requiring surgery, etc.);
- −smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives High-intensity interval training.
Registry label: A: Morning exercise
Group B receives High-intensity interval training.
Registry label: B: Afternoon exercise
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 45 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 48 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: Measured 180 minutes, 240 minutes, 300 minutes and 360 minutes after liquid meal at baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →, 18-24hours after acute exercise bout and >48hours after final exercise bout (after 12 week intervention).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in Adipose tissue dietary fatty acid (DFA) partitioning — measured over Measured 180 minutes, 240 minutes, 300 minutes and 360 minutes after liquid meal at baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →, 18-24hours after acute exercise bout and >48hours after final exercise bout (after 12 week intervention).
Change in lean organ (heart, liver, skeletal muscle) DFA partitioning — measured over Measured 180 minutes, 240 minutes, 300 minutes and 360 minutes after liquid meal at baseline visit, 18-24hours after acute exercise bout and >48hours after final exercise bout (after 12 week intervention).
Change in skeletal muscle ATP fluxes in vivo — measured over Measured 170 minutes before and 30 minutes following liquid meal at baseline visit, 18-24hours after acute exercise bout and >48hours after final exercise bout (after 12 week intervention).
Change in glucose controlControl groupThe group a new treatment is measured against.Read more → — measured over Measured continuously 2-3 days before and 2-3 days after first and final exercise session, after 12-week exercise intervention.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05123963 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About High-intensity interval trainingBehavioural
3 times per week high-intensity interval training (HIIT) on a cycle ergometer for 12 weeks.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 45 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 45 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Measured 180 minutes, 240 minutes, 300 minutes and 360 minutes after liquid meal at baseline visitBaselineYour starting measurements, taken before treatment begins.Read more →, 18-24hours after acute exercise bout and >48hours after final exercise bout (after 12 week intervention)..
The study as a whole is currently expected to finish around 2027-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 48 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Sherbrooke, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Exercise is well-known to improve skeletal muscle energy metabolism and is an established intervention to improve muscle insulin sensitivity and to counter the development of type 2 diabetes (T2D). However, given the 24h rhythmicity in substrate metabolism previously observed in healthy, lean men and the lack of such rhythmicity in men with insulin-resistance, the investigator hypothesize that appropriate timing of exercise training can maximize the metabolic health effects of exercise. Indeed, a preliminary study in humans revealed that afternoon high-intensity interval training (HIIT) exercise was more effective than morning exercise in improving 24h blood glucose levels in men with T2D. Another recent study in mice showed that the time of day is a critical factor in augmenting the beneficial effects of exercise on the skeletal muscle metabolome as well as on whole-body energy homeostasis. However, human studies that specifically target the impact of timing of exercise training on glucose homeostasis and metabolic health are scarce and the potential underlying mechanisms largely unknown. The overarching goals of this project is to improve 24-hour rhythmicity of metabolism in men and women with prediabtes by appropriate timing of exercise and to assess its effect on metabolic health and immune response. Acute and prolonged exercise interventions timed in the morning vs late afternoon will be carried out in individuals with prediabetes to determine whether acute exercise in the afternoon and prolonged exercise training in the afternoon can improve peripheral insulin sensitivity, compared to exercise in the morning, and positively affect adipose tissue dietary fatty acid storage and partitioning of dietary fatty acids in skeletal muscles.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.