Type1diabetesNCT03544684
Fasted Exercise in People With Type 1 Diabetes
A study testing Effects of the type of exercise on blood glucose concentrations in people with Type1diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Effects of the type of exercise on blood glucose concentrations
- Type of treatment
- Lifestyle or therapy programme
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- 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)
- angina
Show all 11Show fewer
- autonomic neuropathy
- taking any medication that affects heart rate
- major surgery planned within 6 weeks of the study
- severe nonproliferative and
- 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: Fasted High-Intensity Interval and Moderate-Intensity Continuous Exercise Are Not Associated With A Detrimental 24-Hour Blood Glucose Profile
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period.
Read the detailed description
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period. Fourteen people with type 1 diabetes (duration of type 1 diabetes 8.2±1.4 years), all on basal-bolus regimen, completed a randomised, counterbalanced, crossover study. Continuous glucose monitoring was used to assess glycaemic control following a single bout of HIT (6 x 1min intervals) and 30 mins of moderate-intensity continuous training (MICT) on separate days, compared to a non-exercise control day (CON). Exercise was undertaken following an overnight fast with omission of short-acting insulin. Capillary blood glucose samples were recorded pre and post-exercise to assess the acute changes in glycaemia during HIT and MICT.
- Conditions
- Type1diabetes
- Being tested
- Effects of the type of exercise on blood glucose concentrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of the type of exercise on blood glucose concentrationsBehavioural
glucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training
| Study group | Role | What they receive |
|---|---|---|
| Control day with no exercise | Experimental | glycaemic profile will be assessed using continuous glucose monitors following a single 24-hour period in which participants performed no exercise Receives: Behavioral: Effects of the type of exercise on blood glucose concentrations |
| High intensity interval training (HIT) | Experimental | glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of high-intensity interval training (HIT) in the morning under fasted conditions Receives: Behavioral: Effects of the type of exercise on blood glucose concentrations |
| moderate intensity continuous training (MICT) | Experimental | glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of moderate-intensity continuous training (MICT) in the morning under fasted conditions Receives: Behavioral: Effects of the type of exercise on blood glucose concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour glycaemic profile
Continuous glucose monitoring will be used to assess the effects of an acute bout of fasted high intensity interval training or moderate intensity continuous training on 24 hour glycaemic profile.
Measured: 24 hours
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- 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
- NCT03544684
- Sponsor's protocol ID
- T1D_PARTA
- Status last verified
- Jun 2018
- First submitted
- 9 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual data available to others
Publications
Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. High-Intensity Interval Training Improves Aerobic Capacity Without a Detrimental Decline in Blood Glucose in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Feb 1;104(2):604-612. doi: 10.1210/jc.2018-01309.
PubMed 30281094Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. Fasted High-Intensity Interval and Moderate-Intensity Exercise Do Not Lead to Detrimental 24-Hour Blood Glucose Profiles. J Clin Endocrinol Metab. 2019 Jan 1;104(1):111-117. doi: 10.1210/jc.2018-01308.
PubMed 30252054
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasted High-Intensity Interval and Moderate-Intensity Continuous Exercise Are Not Associated With A Detrimental 24-Hour Blood Glucose Profile
- ClinicalTrials.gov ID
- NCT03544684
- Acronym / sponsor ID
- T1D_PARTA
- 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.
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period.
Detailed description
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period. Fourteen people with type 1 diabetes (duration of type 1 diabetes 8.2±1.4 years), all on basal-bolus regimen, completed a randomised, counterbalanced, crossover study. Continuous glucose monitoring was used to assess glycaemic control following a single bout of HIT (6 x 1min intervals) and 30 mins of moderate-intensity continuous training (MICT) on separate days, compared to a non-exercise control day (CON). Exercise was undertaken following an overnight fast with omission of short-acting insulin. Capillary blood glucose samples were recorded pre and post-exercise to assess the acute changes in glycaemia during HIT and MICT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control day with no exercise | Experimental | Behavioral: Effects of the type of exercise on blood glucose concentrationsglycaemic profile will be assessed using continuous glucose monitors following a single 24-hour period in which participants performed no exercise |
| High intensity interval training (HIT) | Experimental | Behavioral: Effects of the type of exercise on blood glucose concentrationsglycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of high-intensity interval training (HIT) in the morning under fasted conditions |
| moderate intensity continuous training (MICT) | Experimental | Behavioral: Effects of the type of exercise on blood glucose concentrationsglycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of moderate-intensity continuous training (MICT) in the morning under fasted conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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, uncontrolled hypertension (>180/100 mmHg)
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 |
|---|---|---|
| Effects of the type of exercise on blood glucose concentrationsglucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training | Behavioural | Control day with no exercise, High intensity interval training (HIT), moderate intensity continuous training (MICT) |
Primary outcome
24 hour glycaemic profile
Time frame: 24 hours
Continuous glucose monitoring will be used to assess the effects of an acute bout of fasted high intensity interval training or moderate intensity continuous training on 24 hour glycaemic profile.
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 11 Jun 2018.
- Derived from this study: PubMed 30281094Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. High-Intensity Interval Training Improves Aerobic Capacity Without a Detrimental Decline in Blood Glucose in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Feb 1;104(2):604-612. doi: 10.1210/jc.2018-01309.
- Derived from this study: PubMed 30252054Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. Fasted High-Intensity Interval and Moderate-Intensity Exercise Do Not Lead to Detrimental 24-Hour Blood Glucose Profiles. J Clin Endocrinol Metab. 2019 Jan 1;104(1):111-117. doi: 10.1210/jc.2018-01308.
- Individual participant dataSharing planned: No. There is no plan to make individual data available to others
Related trials for Type1diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
Type 1 Diabetes, type1diabetes
Recruiting
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
Non-Nutritive Sweetener, Type 1 Diabetes
Active, not recruiting
Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
Type1diabetes
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 Effects of the type of exercise on blood glucose concentrations 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 11 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?
24 hour glycaemic profile (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03544684, which also lists 2 linked publications.
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 11 Jun 2018.