Type 2 DiabetesNCT03553524
Circadian High Intensity Interval Training Study
A study testing morning HIIT --> afternoon HIIT and afternoon HIIT --> morning HIIT in people with Type 2 Diabetes and Insulin Independent, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. Read more about this study
- Who is it for?
- Ages 45 to 68 years
- Conditions the study is for
- Type 2 Diabetes, Insulin Independent
- What is being tested?
- morning HIIT --> afternoon HIIT and afternoon HIIT --> morning HIIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 30 Oct 2021to 30 Oct 2022
- 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 45 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 45 - 68 years
- Body Mass Index (BMI): 23 - 33 kg/m2
- Participant diagnosed with Type 2 Diabetes (insulin independent)
- Ability to provide informed consent
- Ability to complete the exercise regiment
Who cannot join
- Medications: Insulin
- Current nicotine user (cigarettes, snus, nicotine gum)
- Past nicotine use less than 6 months before inclusion in the study
- Pre-existing cardiovascular condition: Angina pectoris, Cardiac arrhythmia, Cardiac infarction, Coronary stent / angiography, Cerebrovascular insult, Hypertension
- Pre-existing blood-borne disease: HIV, Hepatitis C, MRSA
- Pre-existing systemic or localized rheumatic illness
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- Cancer
- Pre-existing psychiatric disorder
- Another pre-existing systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time of Day Dependant Effects of High Intensity Interval Training on Blood Glucose Levels in Participants With Type 2 Diabetes
High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.
Read the detailed description
High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes. Additionally, we aim to to elucidate the underlying hormonal changes and fuel utilization preference responsible for the differing blood glucose response.
A randomized cross-over trial with 40 participants with type 2 diabetes will be performed. The participants will be examined on three occasions on an in-patient basis (36-hour hospital visits). On visit 1 baseline (no exercise) measurements will be established. On visit 2 the participants will perform a single bout of HIIT either in the morning (08:30) or afternoon (19:30). After a 1-week washout period, the participants will return for visit 3 and an opposing exercise time. Primarily, the efficacy of the morning and afternoon HIIT will be judged by the continuous glucose monitor (CGM) -based glycaemia measurements. Additionally, during the visits the investigators will collect repeated blood samples to assess the effect of exercise timing on the diurnal hormonal rhythms. Fuel utilization preference will be measured by respiratory exchange ratio (RER)during exercise.
The hypothesis is that afternoon HIIT will be more efficacious in controlling blood glucose values, based on the preliminary data gathered from the 'free living' pilot study. The current study will aim to compare the morning and afternoon exercise in controlled conditions, eliminating the effects of dietary intake, medication and sleep cycle disruption. Additionally, the specific factors responsible for the differing glycaemic response to morning and afternoon exercise will be elucidated.
Preliminary data from the pilot study
A randomised cross-over pilot study with 11 participants with type 2 diabetes in 'free living' conditions has been performed. Glycaemia measurements were collected by continuous glucose monitors (CGMs) for 2 weeks pre-training and for the duration of the study. The participants were assigned to either morning (08:00) or afternoon (16:00) training regime consisting of 6 HIIT occasions over 2 weeks. Following a 2-week 'wash-out' period, the participants performed the opposing exercise training regime. The preliminary results show that HIIT is more efficacious in improving glycaemia when performed in the afternoon, rather than in the morning.
This pilot was a field-based study in 'free-living' individuals, thus the specific factors responsible for the differing blood glucose levels between morning and afternoon exercise trials remain to be elucidated. Now is the aim to perform a study in controlled condition, limiting the effects food intake, medication and sleep-wake cycle disruption and measuring the effects of a single HIIT bout on glycaemia. The hypothesis is that HIIT bout at different times of day diversely affects diurnal hormonal rhythms, accounting for the differing glycaemic responses.
- Conditions
- Type 2 Diabetes, Insulin Independent
- Being tested
- morning HIIT --> afternoon HIIT, afternoon HIIT --> morning HIIT
- Keywords
- Type 2 Diabetes, Insulin independent, HIIT, CGM-based blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morning HIIT --> afternoon HIITOther
Arm 1 will start with morning HIIT at visit 2 and afternoon HIIT at visit 3
afternoon HIIT --> morning HIITOther
Arm 2 will start with afternoon HIIT at visit 2 and morning HIIT at visit 3
| Study group | Role | What they receive |
|---|---|---|
| Morning first | Experimental | Both arms of the study will perform the baseline measurements during visit 1. Arm 1 of the study will perform HIIT at 08:30 during visit 2, and after a 1-week washout period will perform HIIT at 19:30 during visit 3.
HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown. Receives: Other: morning HIIT --> afternoon HIIT |
| Afternoon first | Experimental | Both arms of the study will perform the baseline measurements during visit 1. Arm 2 of the study will perform HIIT at 19:30 during visit 2, and after a 1-week washout period will perform HIIT at 08:30 during visit 3.
HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown. Receives: Other: afternoon HIIT --> morning HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the efficacy of the morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.
Continuous glucose monitor-based blood glucose measurements will be recorded and blood samples will be obtained before and after exercise. Additional repeated blood samples will be collected every 4-6 hours during the stay.
Measured: 36 hours on: visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT)
Secondary outcomes (2)
Blood insulin levels (mIU/l) will be determined in collected blood samples and compared between exercise interventions (morning vs afternoon HIIT) as well as to no-exercise baseline measurements (morning / afternoon HIIT vs baseline).
Measured: Every 4-6 hours during 36 hours on visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT)
Respiratory exchange ratio (RER)
Respiratory exchange ratio (RER) will be determined for the duration of the exercise bout utilizing a face-mask gas collector coupled to indirect calorimeter. RER comparisons will be made between the two exercise interventions (morning vs afternoon HIIT).
Measured: During exercise on visit 2 (Arm 1 - Morning HIIT (08:30) / Arm 2 - Afternoon HIIT (19:30)) and visit 3 (Arm 1 - Afternoon HIIT (19:30) / Arm 2 - Morning HIIT (08:30))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start30 Oct 2021 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Why it stopped: Due to personnel and organizational issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harriet Wallberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553524
- Sponsor's protocol ID
- CircHIIT Study
- Status last verified
- May 2022
- First submitted
- 13 Apr 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Day Dependant Effects of High Intensity Interval Training on Blood Glucose Levels in Participants With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03553524
- Acronym / sponsor ID
- CircHIIT Study
- Conditions
- Type 2 Diabetes, Insulin Independent
- Keywords
- Type 2 Diabetes, Insulin independent, HIIT, CGM-based blood glucose
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to personnel and organizational issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 12 Jun 2018 (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.
High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.
Detailed description
High intensity interval training (HIIT) is a promising intervention for treatment and prevention of type 2 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes. Additionally, we aim to to elucidate the underlying hormonal changes and fuel utilization preference responsible for the differing blood glucose response.
A randomized cross-over trial with 40 participants with type 2 diabetes will be performed. The participants will be examined on three occasions on an in-patient basis (36-hour hospital visits). On visit 1 baseline (no exercise) measurements will be established. On visit 2 the participants will perform a single bout of HIIT either in the morning (08:30) or afternoon (19:30). After a 1-week washout period, the participants will return for visit 3 and an opposing exercise time. Primarily, the efficacy of the morning and afternoon HIIT will be judged by the continuous glucose monitor (CGM) -based glycaemia measurements. Additionally, during the visits the investigators will collect repeated blood samples to assess the effect of exercise timing on the diurnal hormonal rhythms. Fuel utilization preference will be measured by respiratory exchange ratio (RER)during exercise.
The hypothesis is that afternoon HIIT will be more efficacious in controlling blood glucose values, based on the preliminary data gathered from the 'free living' pilot study. The current study will aim to compare the morning and afternoon exercise in controlled conditions, eliminating the effects of dietary intake, medication and sleep cycle disruption. Additionally, the specific factors responsible for the differing glycaemic response to morning and afternoon exercise will be elucidated.
Preliminary data from the pilot study
A randomised cross-over pilot study with 11 participants with type 2 diabetes in 'free living' conditions has been performed. Glycaemia measurements were collected by continuous glucose monitors (CGMs) for 2 weeks pre-training and for the duration of the study. The participants were assigned to either morning (08:00) or afternoon (16:00) training regime consisting of 6 HIIT occasions over 2 weeks. Following a 2-week 'wash-out' period, the participants performed the opposing exercise training regime. The preliminary results show that HIIT is more efficacious in improving glycaemia when performed in the afternoon, rather than in the morning.
This pilot was a field-based study in 'free-living' individuals, thus the specific factors responsible for the differing blood glucose levels between morning and afternoon exercise trials remain to be elucidated. Now is the aim to perform a study in controlled condition, limiting the effects food intake, medication and sleep-wake cycle disruption and measuring the effects of a single HIIT bout on glycaemia. The hypothesis is that HIIT bout at different times of day diversely affects diurnal hormonal rhythms, accounting for the differing glycaemic responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning first | Experimental | Other: morning HIIT --> afternoon HIITBoth arms of the study will perform the baseline measurements during visit 1. Arm 1 of the study will perform HIIT at 08:30 during visit 2, and after a 1-week washout period will perform HIIT at 19:30 during visit 3. HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown. |
| Afternoon first | Experimental | Other: afternoon HIIT --> morning HIITBoth arms of the study will perform the baseline measurements during visit 1. Arm 2 of the study will perform HIIT at 19:30 during visit 2, and after a 1-week washout period will perform HIIT at 08:30 during visit 3. HIIT bout will consist of 3 minutes of warm-up followed by 6 1-minute intervals of full exertion cycling on a cycle ergometer, interspersed by a 1-minute recovery periods and ending with a 3-minute cooldown. |
Who may qualify
- Ages
- 45 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 45 - 68 years
- Body Mass Index (BMI): 23 - 33 kg/m2
- Participant diagnosed with Type 2 Diabetes (insulin independent)
- Ability to provide informed consent
- Ability to complete the exercise regiment
Key exclusion criteria (9 listed)
- Medications: Insulin
- Current nicotine user (cigarettes, snus, nicotine gum)
- Past nicotine use less than 6 months before inclusion in the study
- Pre-existing cardiovascular condition: Angina pectoris, Cardiac arrhythmia, Cardiac infarction, Coronary stent / angiography, Cerebrovascular insult, Hypertension
- Pre-existing blood-borne disease: HIV, Hepatitis C, MRSA
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 |
|---|---|---|
| morning HIIT --> afternoon HIITArm 1 will start with morning HIIT at visit 2 and afternoon HIIT at visit 3 | Other | Morning first |
| afternoon HIIT --> morning HIITArm 2 will start with afternoon HIIT at visit 2 and morning HIIT at visit 3 | Other | Afternoon first |
Primary outcome
Compare the efficacy of the morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes.
Time frame: 36 hours on: visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT)
Continuous glucose monitor-based blood glucose measurements will be recorded and blood samples will be obtained before and after exercise. Additional repeated blood samples will be collected every 4-6 hours during the stay.
2 secondary outcomes
Blood insulin levels (mIU/l) will be determined in collected blood samples and compared between exercise interventions (morning vs afternoon HIIT) as well as to no-exercise baseline measurements (morning / afternoon HIIT vs baseline).
Time frame: Every 4-6 hours during 36 hours on visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT)
Respiratory exchange ratio (RER)
Time frame: During exercise on visit 2 (Arm 1 - Morning HIIT (08:30) / Arm 2 - Afternoon HIIT (19:30)) and visit 3 (Arm 1 - Afternoon HIIT (19:30) / Arm 2 - Morning HIIT (08:30))
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 24 May 2022.
- Individual participant dataSharing planned: Undecided
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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 morning HIIT --> afternoon HIIT and afternoon HIIT --> morning HIIT in people with Type 2 Diabetes and Insulin Independent, run by Karolinska Institutet at 1 site in Sweden.
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 5 inclusion and 9 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 24 May 2022. 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 Sweden. 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 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?
Compare the efficacy of the morning and afternoon HIIT in lowering blood glucose values in participants with type 2 diabetes. (time frame: 36 hours on: visit 1 (baseline / no exercise), visit 2 (Arm 1 - Morning HIIT / Arm 2 - Afternoon HIIT) and visit 3 (Arm 1 - Afternoon HIIT / Arm 2 - Morning HIIT)). 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 24 May 2022; AzTrials last refreshed its copy on 5 Nov 2026.