Type1diabetesNCT03545841
HIT in People With Type 1 Diabetes
A study testing HIT and MICT in people with Type1diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
Few people with type 1 diabetes achieve exercise guidelines and many programmes designed to increase physical activity have failed. High-intensity interval training (HIT) has been shown to be a time-efficient alternative to traditional moderate-intensity continuous training (MICT) in various groups without type 1… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type1diabetes
- What is being tested?
- HIT and MICT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2015to 10 Oct 2017
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- duration of type 1 diabetes >6 months
- basal bolus regimen
- no significant history of hyper- or hypoglycaemia (determined from medical history)
Who cannot join
- duration of type 1 diabetes <6 months,
- insulin pump therapy
- significant history of hyper- or hypoglycaemia (determined from medical history)
- obesity (BMI >30 kg∙m-2)
- pregnancy or planning pregnancy
- uncontrolled hypertension (>180/100 mmHg)
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- angina, autonomic neuropathy
- taking any medication that affects heart rate
- major surgery planned within 6 weeks of the study
- severe nonproliferative
- unstable proliferative retinopathy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
About this study
Official title: High-Intensity Interval Training Improves Aerobic Capacity and Abolishes the Decline in Blood Glucose Observed During Moderate-Intensity Continuous Training Sessions in People With Type 1 Diabetes
Few people with type 1 diabetes achieve exercise guidelines and many programmes designed to increase physical activity have failed. High-intensity interval training (HIT) has been shown to be a time-efficient alternative to traditional moderate-intensity continuous training (MICT) in various groups without type 1 diabetes. A single bout of HIT does not increase the risk of hypoglycaemia in people with type 1 diabetes. This study aimed to assess whether HIT a safe, effective and time-efficient training strategy to improve cardio-metabolic health and reduce the risk of hypoglycaemia in people with type 1 diabetes.
Read the detailed description
This study aimed to investigate whether 1) six weeks of high-intensity interval training (HIT) induces similar improvements in cardio-metabolic health markers as moderate-intensity continuous training (MICT) in people with type 1 diabetes, and 2) whether HIT abolishes acute reductions in plasma glucose observed following MICT sessions. Fourteen sedentary individuals with type 1 diabetes (n=7 per group) completed six weeks of HIT or MICT 3 times per week. Pre- and post-training measurements were made of 24h interstitial glucose profiles (using continuous glucose monitors (CGMS)) and cardio-metabolic health markers (V ̇O2peak, blood lipid profile and aortic pulse wave velocity; aPWV). Capillary blood glucose concentrations were assessed before and after exercise sessions throughout the training programme to investigate changes in blood glucose during exercise in the fed state.
- Conditions
- Type1diabetes
- Being tested
- HIT, MICT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITOther
Participants completed 6 weeks of HIT
MICTOther
Participants completed 6 weeks of MICT
| Study group | Role | What they receive |
|---|---|---|
| HIT training | Experimental | 6 weeks of high-intensity interval training (HIT) Receives: Other: HIT |
| Moderate intensity training | Experimental | 6 weeks of moderate-intensity continuous training (MICT) Receives: Other: MICT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal aerobic capacity
Maximal aerobic capacity test pre and post 6-week training intervention
Measured: change in baseline maximal aerobic capacity at 6 weeks
Secondary outcomes (1)
Vascular stiffness
Aortic pulse wave velocity to measure vascular stiffness
Measured: change in baseline vascular stiffness at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start9 Mar 2015
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Shepherd, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545841
- Sponsor's protocol ID
- T1D_PARTB
- Status last verified
- Jun 2018
- First submitted
- 9 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to make data available to others
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Interval Training Improves Aerobic Capacity and Abolishes the Decline in Blood Glucose Observed During Moderate-Intensity Continuous Training Sessions in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03545841
- Acronym / sponsor ID
- T1D_PARTB
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 4 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.
Few people with type 1 diabetes achieve exercise guidelines and many programmes designed to increase physical activity have failed. High-intensity interval training (HIT) has been shown to be a time-efficient alternative to traditional moderate-intensity continuous training (MICT) in various groups without type 1 diabetes. A single bout of HIT does not increase the risk of hypoglycaemia in people with type 1 diabetes. This study aimed to assess whether HIT a safe, effective and time-efficient training strategy to improve cardio-metabolic health and reduce the risk of hypoglycaemia in people with type 1 diabetes.
Detailed description
This study aimed to investigate whether 1) six weeks of high-intensity interval training (HIT) induces similar improvements in cardio-metabolic health markers as moderate-intensity continuous training (MICT) in people with type 1 diabetes, and 2) whether HIT abolishes acute reductions in plasma glucose observed following MICT sessions. Fourteen sedentary individuals with type 1 diabetes (n=7 per group) completed six weeks of HIT or MICT 3 times per week. Pre- and post-training measurements were made of 24h interstitial glucose profiles (using continuous glucose monitors (CGMS)) and cardio-metabolic health markers (V ̇O2peak, blood lipid profile and aortic pulse wave velocity; aPWV). Capillary blood glucose concentrations were assessed before and after exercise sessions throughout the training programme to investigate changes in blood glucose during exercise in the fed state.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIT training | Experimental | Other: HIT6 weeks of high-intensity interval training (HIT) |
| Moderate intensity training | Experimental | Other: MICT6 weeks of moderate-intensity continuous training (MICT) |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- duration of type 1 diabetes >6 months
- basal bolus regimen
- no significant history of hyper- or hypoglycaemia (determined from medical history)
Key exclusion criteria (11 listed)
- duration of type 1 diabetes <6 months,
- insulin pump therapy
- significant history of hyper- or hypoglycaemia (determined from medical history)
- obesity (BMI >30 kg∙m-2)
- pregnancy or planning pregnancy
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 |
|---|---|---|
| HITParticipants completed 6 weeks of HIT | Other | HIT training |
| MICTParticipants completed 6 weeks of MICT | Other | Moderate intensity training |
Primary outcome
Maximal aerobic capacity
Time frame: change in baseline maximal aerobic capacity at 6 weeks
Maximal aerobic capacity test pre and post 6-week training intervention
1 secondary outcome
Vascular stiffness
Time frame: change in baseline vascular stiffness at 6 weeks
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 4 Jun 2018.
- Individual participant dataSharing planned: No. No plans to make data available to others
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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 HIT and MICT in people with Type1diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
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 3 inclusion and 11 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 4 Jun 2018. 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 Kingdom. 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?
Maximal aerobic capacity (time frame: change in baseline maximal aerobic capacity at 6 weeks). 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 4 Jun 2018.