Diabetes Mellitus, Type 1TAILOR/1bNCT06080542
Influence of Aerobic Exercise and HIIT on Glycemic Control in Adult Men With Type 1 Diabetes (TAILOR/1b)
A study testing Aerobic and High-intensity interval training in people with Diabetes Mellitus, Type 1, run by University of Valencia at 1 site in Spain.
Trial summary
Physical exercise is one of the main recommendations included in clinical guidelines for people with type 1 diabetes (T1D) because it is associated with substantially lower cardiovascular and overall mortality risks. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Aerobic and High-intensity interval training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 15 Jul 2023
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- age between 18-40 years
- T1D with a diabetes duration for more than 2 years
- glycated hemoglobin (HbA1c) < 8.5% (<69 mmol mol-1)
- stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose
- multiple daily injections
- weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional
Who cannot join
- clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
Trial locations and contacts
1 site in 1 country.
About this study
Physical exercise is one of the main recommendations included in clinical guidelines for people with type 1 diabetes (T1D) because it is associated with substantially lower cardiovascular and overall mortality risks. Adherence to regular physical activity is low in the T1D population due to factors like time limitations, no access to appropriate equipment at home, or economic costs. High-intensity interval training (HIIT) has been proposed as a time-efficient methodology, consisting of sessions of short duration and high intensity exercises. An easier and cheaper training alternative for HIIT is exercising with elastic bands, either in a clinic or at home. Even so, training with elastic bands in T1D in combination with the HIIT method has not been compared to aerobic training. Besides, it is necessary to understand the glycemic impact of both kinds of exercise in order to build better artificial pancreas systems able to deal with exercise automatically. The aim of the study will be to determine the impact of aerobic exercise versus high-intensity interval training (HIIT) exercise on glycemic control.
Read the detailed description
This HIIT modality presents differences with respect to other studies since it consists of strength exercises with elastic bands. This novelty represents an advantage because it can be an easier training alternative to perform in a clinical or home setting, compared to previous studies where cycle ergometer is used. Thus, one session of each type of exercise will be performed.
Prior to the exercise sessions, an incremental exercise test will be performed to determine the working power in the cycle ergometer. At the beginning of the test, subjects will be sit quietly on the cycle ergometer for 3 min (0 W) before they will start the warm-up period of 3 min with cycling at a workload of 60 W. Then, the workload will increase by 40 W every 3 min until volitional exhaustion. Finally, 3 min active recovery at 60 W followed by 3 min passive recovery (0 W) will be conducted on the cycle ergometer. Lactate turn point 1 (LTP1) and maximum power (Pmax) will be determined in order to prescribe the exercise intensity. Additionally, patients will conduct a familiarization session with the strength exercises in order to adapt the participants to exercises with elastic bands. Thus, the subjects will perform two sets of twelve repetitions of the exercises.
The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 60 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test.
The elastic band protocol is a modification of the HIIT protocols used by previous authors changing body weight exercises by exercises with TheraBand CLX. The exercise program is chosen to involve large muscle groups simulating conventional bodybuilding exercises by applying the external load to the elastic band's resistance. Four exercises of upper limb (bench press, seated dumbbell, biceps curl, and seated row) and four of lower limb (squats, stiff-legged deadlift, hamstring curl exercise, and quadriceps curl exercise) are chosen, which are intercalated in the program without doing two consecutive exercises of the same area. All exercises are done with both arms or legs at the same time.
Prior to HIIT session, participants will carry out a warm-up consisting of 3 minutes at 60 W on the cycle ergometer and 15 no-load shoulder flexo-extensions. Session consists of two set of exercise intervals of 20s separated by 10s of rest (i.e. 4min in total) with a rest of 3 minutes between both series, making at each interval a different exercise resisted by the elastic band. The participants have to choose a width in the elastic band grip that supposed a maximum effort for the 20s of each exercise. Subjects will be encouraged to perform as many repetitions per interval as possible while maintaining correct form.
Perceived exertion will be used to determine the correct intensity of HIIT sessions. Immediately following each set of eight intervals, subjects will report ratings of perceived exertion using the Thera-Band resistance exercise scale of perceived exertion with Thera-Band® resistance bands. HIIT sessions correspond to a "Maximal". Heart rate will be measured continuously via chest belt telemetry (Polar H10) during all tests and also averaged over 5s.
A sample size of n=40 will be chosen for each study.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Aerobic, High-intensity interval training
- Keywords
- aerobic, men, glycemic, hiit
- Medical subject headings
- Diabetes Mellitus, Type 1, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AerobicProcedure or surgery
This session will consist of an aerobic training session performed on a cycle ergometer.
High-intensity interval trainingProcedure or surgery
This session will consist of a HIIT performed with elastic bands
| Study group | Role | What they receive |
|---|---|---|
| Aerobic session | Experimental | The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 60 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. Receives: Procedure: Aerobic |
| High-intensity interval training | Experimental | Our elastic band protocol is a modification of the HIIT protocols used by previous authors changing body weight exercises by exercises with TheraBand CLX. The exercise program is chosen to involve large muscle groups simulating conventional bodybuilding exercises by applying the external load to the elastic band's resistance. Four exercises of upper limb (bench press, seated dumbbell, shoulder press, and seated row) and four of lower limb (squats, stiff-legged deadlift, hamstring curl exercise, and quadriceps curl exercise) are chosen, which are intercalated in the program without doing two consecutive exercises of the same area. All exercises are done with both arms or legs at the same time. Receives: Procedure: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose Glucose control
Blood glucose (mg/dL) will be measured through blood draws and YSI analysis
Measured: The evaluated time points for exercise will be at 20 and 10 minutes before the session, at the beginning of the training and at 10, 20, and 30 minutes during the interval, and at 10 and 20 minutes after finishing the training.
Interstitial glucose
Interstitial glucose will be measured using the Dexcom G6 and FreeStyle 2 as a continuous glucose meters.
Mean glucose, glycemic variability (measured using the Coefficient of Variation-CV) and the time spent at each glucose range [euglycemia (70-180 mg/dL) or Time in range (TIR), level 1 or mild hypoglycemia (54-70 mg/dL), level 2 or severe hypoglycemia (<54 mg/dL), level 1 hyperglycemia (180-250 mg/dL) and level 2 hyperglycemia (>250 mg/ dL)] will be evaluated with continuous glucose meters during 6 h, 12 h, and 24 h following both exercise sessions. Glucose before exercise were monitored using samples from a continuous glucose meters corresponding to a window of 24 hours before the exercise that exactly correspond to the clock times of the patient in the 24h after the exercise
Measured: 24 h pre-intervention and 24h post-intervention
Secondary outcomes (1)
Lactate
Lactate concentration (mmol/L) will be performed through blood extractions and measured using the YSI 2500
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Feb 2023
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Two interventions will be carried out in a single group, one aerobic session and HIIT session.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER), Ministerio de Ciencia e Innovación, Spain, European Regional Development Fund, Universitat Politècnica de València
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080542
- Sponsor's protocol ID
- 1587001
- Acronym
- TAILOR/1b
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cuerda Del Pino A, Martin-San Agustin R, Jose Laguna Sanz A, Diez JL, Palanca A, Rossetti P, Gumbau-Gimenez M, Ampudia-Blasco FJ, Bondia J. Accuracy of Two Continuous Glucose Monitoring Devices During Aerobic and High-Intensity Interval Training in Individuals with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jun;26(6):411-419. doi: 10.1089/dia.2023.0535.
PubMed 38215205
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Aerobic Exercise and HIIT on Glycemic Control in Adult Men With Type 1 Diabetes (TAILOR/1b)
- ClinicalTrials.gov ID
- NCT06080542
- Acronym / sponsor ID
- TAILOR/1b / 1587001
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- aerobic, men, glycemic, hiit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Consorcio Centro de Investigación Biomédica en Red (CIBER), Ministerio de Ciencia e Innovación, Spain, European Regional Development Fund, Universitat Politècnica de València
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 12 Oct 2023 (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.
Physical exercise is one of the main recommendations included in clinical guidelines for people with type 1 diabetes (T1D) because it is associated with substantially lower cardiovascular and overall mortality risks. Adherence to regular physical activity is low in the T1D population due to factors like time limitations, no access to appropriate equipment at home, or economic costs. High-intensity interval training (HIIT) has been proposed as a time-efficient methodology, consisting of sessions of short duration and high intensity exercises. An easier and cheaper training alternative for HIIT is exercising with elastic bands, either in a clinic or at home. Even so, training with elastic bands in T1D in combination with the HIIT method has not been compared to aerobic training. Besides, it is necessary to understand the glycemic impact of both kinds of exercise in order to build better artificial pancreas systems able to deal with exercise automatically. The aim of the study will be to determine the impact of aerobic exercise versus high-intensity interval training (HIIT) exercise on glycemic control.
Detailed description
This HIIT modality presents differences with respect to other studies since it consists of strength exercises with elastic bands. This novelty represents an advantage because it can be an easier training alternative to perform in a clinical or home setting, compared to previous studies where cycle ergometer is used. Thus, one session of each type of exercise will be performed.
Prior to the exercise sessions, an incremental exercise test will be performed to determine the working power in the cycle ergometer. At the beginning of the test, subjects will be sit quietly on the cycle ergometer for 3 min (0 W) before they will start the warm-up period of 3 min with cycling at a workload of 60 W. Then, the workload will increase by 40 W every 3 min until volitional exhaustion. Finally, 3 min active recovery at 60 W followed by 3 min passive recovery (0 W) will be conducted on the cycle ergometer. Lactate turn point 1 (LTP1) and maximum power (Pmax) will be determined in order to prescribe the exercise intensity. Additionally, patients will conduct a familiarization session with the strength exercises in order to adapt the participants to exercises with elastic bands. Thus, the subjects will perform two sets of twelve repetitions of the exercises.
The aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 60 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test.
The elastic band protocol is a modification of the HIIT protocols used by previous authors changing body weight exercises by exercises with TheraBand CLX. The exercise program is chosen to involve large muscle groups simulating conventional bodybuilding exercises by applying the external load to the elastic band's resistance. Four exercises of upper limb (bench press, seated dumbbell, biceps curl, and seated row) and four of lower limb (squats, stiff-legged deadlift, hamstring curl exercise, and quadriceps curl exercise) are chosen, which are intercalated in the program without doing two consecutive exercises of the same area. All exercises are done with both arms or legs at the same time.
Prior to HIIT session, participants will carry out a warm-up consisting of 3 minutes at 60 W on the cycle ergometer and 15 no-load shoulder flexo-extensions. Session consists of two set of exercise intervals of 20s separated by 10s of rest (i.e. 4min in total) with a rest of 3 minutes between both series, making at each interval a different exercise resisted by the elastic band. The participants have to choose a width in the elastic band grip that supposed a maximum effort for the 20s of each exercise. Subjects will be encouraged to perform as many repetitions per interval as possible while maintaining correct form.
Perceived exertion will be used to determine the correct intensity of HIIT sessions. Immediately following each set of eight intervals, subjects will report ratings of perceived exertion using the Thera-Band resistance exercise scale of perceived exertion with Thera-Band® resistance bands. HIIT sessions correspond to a "Maximal". Heart rate will be measured continuously via chest belt telemetry (Polar H10) during all tests and also averaged over 5s.
A sample size of n=40 will be chosen for each study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two interventions will be carried out in a single group, one aerobic session and HIIT session.
| Arm | Type | Receives |
|---|---|---|
| Aerobic session | Experimental | Procedure: AerobicThe aerobic exercise session will begin with a 3 min resting period (sitting quietly on the cycle ergometer (0 W), followed by a 3 min warm-up at 60 W and a stepwise intensity increase by 20 W / min (to control for day-to-day variations in exercise response) until the 5% of Pmax from IET above PLTP1 is achieved (i.e. moderate steady state walking or low-intensity running or cycling). This target workload will be maintained for 30 min. Active and passive recovery periods of 3 min each will be the same as the incremental test. |
| High-intensity interval training | Experimental | Procedure: High-intensity interval trainingOur elastic band protocol is a modification of the HIIT protocols used by previous authors changing body weight exercises by exercises with TheraBand CLX. The exercise program is chosen to involve large muscle groups simulating conventional bodybuilding exercises by applying the external load to the elastic band's resistance. Four exercises of upper limb (bench press, seated dumbbell, shoulder press, and seated row) and four of lower limb (squats, stiff-legged deadlift, hamstring curl exercise, and quadriceps curl exercise) are chosen, which are intercalated in the program without doing two consecutive exercises of the same area. All exercises are done with both arms or legs at the same time. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age between 18-40 years
- T1D with a diabetes duration for more than 2 years
- glycated hemoglobin (HbA1c) < 8.5% (<69 mmol mol-1)
- stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose
- multiple daily injections
Key exclusion criteria (1 listed)
- clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
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 |
|---|---|---|
| AerobicThis session will consist of an aerobic training session performed on a cycle ergometer. | Procedure or surgery | Aerobic session |
| High-intensity interval trainingThis session will consist of a HIIT performed with elastic bands | Procedure or surgery | High-intensity interval training |
Primary outcome
Blood glucose Glucose control
Time frame: The evaluated time points for exercise will be at 20 and 10 minutes before the session, at the beginning of the training and at 10, 20, and 30 minutes during the interval, and at 10 and 20 minutes after finishing the training.
Blood glucose (mg/dL) will be measured through blood draws and YSI analysis
Interstitial glucose
Time frame: 24 h pre-intervention and 24h post-intervention
Interstitial glucose will be measured using the Dexcom G6 and FreeStyle 2 as a continuous glucose meters. Mean glucose, glycemic variability (measured using the Coefficient of Variation-CV) and the time spent at each glucose range [euglycemia (70-180 mg/dL) or Time in range (TIR), level 1 or mild hypoglycemia (54-70 mg/dL), level 2 or severe hypoglycemia (<54 mg/dL), level 1 hyperglycemia (180-250 mg/dL) and level 2 hyperglycemia (>250 mg/ dL)] will be evaluated with continuous glucose meters during 6 h, 12 h, and 24 h following both exercise sessions. Glucose before exercise were monitored using samples from a continuous glucose meters corresponding to a window of 24 hours before the exercise that exactly correspond to the clock times of the patient in the 24h after the exercise
1 secondary outcome
Lactate
Time frame: pre-intervention and immediately after the intervention
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 19 Oct 2023.
- Derived from this study: PubMed 38215205Cuerda Del Pino A, Martin-San Agustin R, Jose Laguna Sanz A, Diez JL, Palanca A, Rossetti P, Gumbau-Gimenez M, Ampudia-Blasco FJ, Bondia J. Accuracy of Two Continuous Glucose Monitoring Devices During Aerobic and High-Intensity Interval Training in Individuals with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jun;26(6):411-419. doi: 10.1089/dia.2023.0535.
- Individual participant dataSharing planned: No
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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 Aerobic and High-intensity interval training in people with Diabetes Mellitus, Type 1, run by University of Valencia at 1 site in Spain.
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 1 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 19 Oct 2023. 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 Spain. 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?
Blood glucose Glucose control (time frame: The evaluated time points for exercise will be at 20 and 10 minutes before the session, at the beginning of the training and at 10, 20, and 30 minutes during the interval, and at 10 and 20 minutes after finishing the training.). 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?
On the ClinicalTrials.gov record for NCT06080542, which also lists 1 linked publication.
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 19 Oct 2023.