Diabetes Mellitus, Type 1HI1TNCT04664205
Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes
A study testing High Intensity Interval Exercise and Moderate Intensity Continuous Exercise in people with Diabetes Mellitus, Type 1, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inadequate knowledge… Read more about this study
- Who is it for?
- Ages 18 to 51 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- High Intensity Interval Exercise and Moderate Intensity Continuous Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin
- Last hemoglobin A1c <9%
- 18-51 years
- Duration of T1D: ≥ 1 year
- Body mass index (BMI) <30 kg/m^2
- Generally healthy, with no conditions that could influence the outcome of the trial, and in the judgement of the investigators is a good candidate for the study, based on a review of health history
Who cannot join
- Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
- Physician diagnosis of peripheral neuropathy with insensate feet
- Physician diagnosis of autonomic neuropathy
- Medications: beta-blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives; any hypoglycemic agent other than insulin.
- Severe hypoglycemic event defined as the individual requiring a third party of hospitalization in the last 6 months
- Diabetic ketoacidosis in the last 6 months
Show all 11Show fewer
- Has a closed-loop pump and not willing to use manual mode
- Physician diagnosis of cardiovascular disease that would affect exercise tolerance
- Currently doing HIIT
- Severely impaired hearing or speech
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27599
About this study
Official title: Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous Training in Adults With Type I Diabetes
Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inadequate knowledge about exercise. Unlike traditional moderate intensity continuous training (MICT) which requires extended periods of time, high intensity interval training (HIIT) requires minimal time (~10 minutes of exercise per session), with the potential to rapidly stimulate mitochondrial biogenesis and metabolism. The extent to which these exercise strategies alter metabolomic signatures of carbohydrate, fat, and amino acid metabolism in T1D is unknown. The overall goal of the proposed project is to identify the acute metabolic effects and physiological modifiers of HIIT compared to MICT and control (CON) using metabolomic profiling and cardiometabolic assessments in 14 adults with T1D. Using a randomized cross-over approach, the primary aim is to compare the metabolomics response immediately post, 1 hr post, and glycemic control through 48 hrs after HIIT, compared to MICT matched for total energy expenditure, versus a no exercise CON. An additional aim will be to characterize the influence of biological sex and physiological outcomes (i.e. body composition, lean mass, visceral fat) on the metabolomics profile of these subjects. Outcomes from the present study, with existing data from our team, will lay the foundation for a larger diet and exercise lifestyle intervention that will ultimately lead to changes in clinical practice to co-manage glycemia and cardiometabolic comorbidities.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- High Intensity Interval Exercise, Moderate Intensity Continuous Exercise, Control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval ExerciseOther
One session of high intensity interval exercise
Moderate Intensity Continuous ExerciseOther
One session of calorically matched moderate intensity exercise
ControlOther
No exercise, resting measures
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training, Moderate Intensity Continuous Training, Control | Experimental | Participants randomly assigned to this arm will first receive high intensity interval training and then randomly assigned to both moderate intensity continuous training and control session, on different days. Receives: Other: High Intensity Interval Exercise; Other: Moderate Intensity Continuous Exercise; Other: Control |
| Moderate Intensity Continuous Training, High Intensity Training, Control | Experimental | Participants randomly assigned to this arm will first receive moderate intensity continuous training then randomly assigned to both high intensity interval training and a control session, on different days. Receives: Other: High Intensity Interval Exercise; Other: Moderate Intensity Continuous Exercise; Other: Control |
| Control session, High intensity interval training, moderate intensity continuous training | Experimental | Participants randomly assigned to this arm will first complete a control session (no exercise) and then randomly assigned to both by a high intensity interval training and moderate intensity continuous training session, on different days. Receives: Other: High Intensity Interval Exercise; Other: Moderate Intensity Continuous Exercise; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Energy Expenditure Between HIIT and MICT
Energy expenditure measured via indirect calorimetry (kcals) during exercise.
Measured: During exercise
Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism
Lactate measured using capillary finger prick (mmol/L).
Measured: Baseline, 1 hour post exercise
Secondary outcomes (1)
Change in Continuous Glucose After Exercise Into Overnight
Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep.
Measured: Immediately post-exercise and Overnight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Feb 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Diabetes Research Center
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664205
- Sponsor's protocol ID
- 20-3100
- Acronym
- HI1T
- Status last verified
- Feb 2022
- First submitted
- 4 Dec 2020
- Last updated
- 26 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic, Hormonal, and Physiological Characterization of Isoenergetic High Intensity Interval Training and Moderate Intensity Continuous Training in Adults With Type I Diabetes
- ClinicalTrials.gov ID
- NCT04664205
- Acronym / sponsor ID
- HI1T / 20-3100
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Diabetes Research Center
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Posted 26 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inadequate knowledge about exercise. Unlike traditional moderate intensity continuous training (MICT) which requires extended periods of time, high intensity interval training (HIIT) requires minimal time (~10 minutes of exercise per session), with the potential to rapidly stimulate mitochondrial biogenesis and metabolism. The extent to which these exercise strategies alter metabolomic signatures of carbohydrate, fat, and amino acid metabolism in T1D is unknown. The overall goal of the proposed project is to identify the acute metabolic effects and physiological modifiers of HIIT compared to MICT and control (CON) using metabolomic profiling and cardiometabolic assessments in 14 adults with T1D. Using a randomized cross-over approach, the primary aim is to compare the metabolomics response immediately post, 1 hr post, and glycemic control through 48 hrs after HIIT, compared to MICT matched for total energy expenditure, versus a no exercise CON. An additional aim will be to characterize the influence of biological sex and physiological outcomes (i.e. body composition, lean mass, visceral fat) on the metabolomics profile of these subjects. Outcomes from the present study, with existing data from our team, will lay the foundation for a larger diet and exercise lifestyle intervention that will ultimately lead to changes in clinical practice to co-manage glycemia and cardiometabolic comorbidities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training, Moderate Intensity Continuous Training, Control | Experimental | Other: High Intensity Interval Exercise, Other: Moderate Intensity Continuous Exercise, Other: ControlParticipants randomly assigned to this arm will first receive high intensity interval training and then randomly assigned to both moderate intensity continuous training and control session, on different days. |
| Moderate Intensity Continuous Training, High Intensity Training, Control | Experimental | Other: High Intensity Interval Exercise, Other: Moderate Intensity Continuous Exercise, Other: ControlParticipants randomly assigned to this arm will first receive moderate intensity continuous training then randomly assigned to both high intensity interval training and a control session, on different days. |
| Control session, High intensity interval training, moderate intensity continuous training | Experimental | Other: High Intensity Interval Exercise, Other: Moderate Intensity Continuous Exercise, Other: ControlParticipants randomly assigned to this arm will first complete a control session (no exercise) and then randomly assigned to both by a high intensity interval training and moderate intensity continuous training session, on different days. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin
- Last hemoglobin A1c <9%
- 18-51 years
- Duration of T1D: ≥ 1 year
- Body mass index (BMI) <30 kg/m^2
Key exclusion criteria (11 listed)
- Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
- Physician diagnosis of peripheral neuropathy with insensate feet
- Physician diagnosis of autonomic neuropathy
- Medications: beta-blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives; any hypoglycemic agent other than insulin.
- Severe hypoglycemic event defined as the individual requiring a third party of hospitalization in the last 6 months
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 |
|---|---|---|
| High Intensity Interval ExerciseOne session of high intensity interval exercise | Other | Control session, High intensity interval training, moderate intensity continuous training, High intensity interval training, Moderate Intensity Continuous Training, Control, Moderate Intensity Continuous Training, High Intensity Training, Control |
| Moderate Intensity Continuous ExerciseOne session of calorically matched moderate intensity exercise | Other | Control session, High intensity interval training, moderate intensity continuous training, High intensity interval training, Moderate Intensity Continuous Training, Control, Moderate Intensity Continuous Training, High Intensity Training, Control |
| ControlNo exercise, resting measures | Other | Control session, High intensity interval training, moderate intensity continuous training, High intensity interval training, Moderate Intensity Continuous Training, Control, Moderate Intensity Continuous Training, High Intensity Training, Control |
Primary outcome
Mean Energy Expenditure Between HIIT and MICT
Time frame: During exercise
Energy expenditure measured via indirect calorimetry (kcals) during exercise.
Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism
Time frame: Baseline, 1 hour post exercise
Lactate measured using capillary finger prick (mmol/L).
1 secondary outcome
Change in Continuous Glucose After Exercise Into Overnight
Time frame: Immediately post-exercise and Overnight
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Abbie Smith-Ryan, PhD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Exercise and Moderate Intensity Continuous Exercise in people with Diabetes Mellitus, Type 1, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 6 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 26 Jul 2024. 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 States. 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?
Yes. Results are posted in the registry (first posted 26 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Energy Expenditure Between HIIT and MICT (time frame: During exercise). The study lists 2 primary outcomes in all. 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 26 Jul 2024.