Diabetes Mellitus, Type 1NCT06680557
Exercises on Children and Adolescents With Type 1 Diabetes Mellitus (T1DM)
A study testing Aerobic and resistance exercises in people with Diabetes Mellitus, Type 1, run by Sohag University at 1 site in Egypt.
Trial summary
This study aimed to assess the effect of aerobic and resistance exercise on postprandial blood glucose levels in children and adolescents aged 10 - 18 years, diagnosed with type 1 diabetes mellitus (T1DM) for at least 1 year, attending the Pediatric diabetes clinic at Sohag University Hospital and using multiple daily… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Aerobic and resistance exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 31 Aug 2025
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year
Who cannot join
- Children and adolescents with associated diseases such as autoimmune hypothyroidism or celiac disease and those with diabetes-related complications such as diabetic neuropathy, retinopathy or nephropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Types of Exercises on Postprandial Blood Glucose Levels in Children and Adolescents With Type 1 Diabetes Mellitus
This study aimed to assess the effect of aerobic and resistance exercise on postprandial blood glucose levels in children and adolescents aged 10 - 18 years, diagnosed with type 1 diabetes mellitus (T1DM) for at least 1 year, attending the Pediatric diabetes clinic at Sohag University Hospital and using multiple daily insulin (MDI) regimen.
Read the detailed description
The participants will be admitted at the pediatric department, Sohag University Hospital for 1 week. Full history taking, thorough clinical examination, review of participants' medical files and assessment of their basal insulin doses ,Insulin to carbohydrate ratio(ICR) and Insulin sensitivity factor (ISF) will be done if required. During hospitalization, the study participants will be familiarized with the types of the exercises used and how to perform each exercise carefully with the help of an exercise specialist before the experimental sessions. The pre-exercise lunch meal will be standardized to provide 30% of the total daily caloric requirement for the study participant (50% carbohydrate, 30% fat and 20% protein). The meal will consist of rice, chicken breast, vegetables and fruits. The Lunch meals will be consumed at the pediatric department, Sohag university hospital at 2 PM. The meal will be consumed within 20 minutes. Each participant will be assigned to perform either the aerobic or the resistance exercise sessions following the lunch meal in a random sequence by the withdrawal of a sealed envelope containing a paper with a written random sequence of the two exercise sessions. The envelope will be withdrawn randomly and opened immediately before the first exercise session. The other type of exercise session will be performed after 48 hours.
Participants will wear a bracelet heart rate monitor during the exercise sessions. Each participant will perform each of the following 2 exercise sessions 30 minutes after the lunch meal in a random sequence with 48-hour period between the 2 exercise sessions
- Aerobic exercise session: A 30-minutes of brisk walking exercise on an indoor track without speed walking or running .
- Resistant exercise session: A 30-minutes of resistance exercise using rubber bands including warm-up and cool-down periods. Rubber band exercises are composed of seven exercises: squat, leg extension, pull apart, seated row, standing biceps curl, overhead press and lateral raise. Each exercise consists of three sets of 10 repetitions with 1 minute rest between each exercise set.
Following the exercise session, participants will be allowed to perform only sedentary activities. No food or drink - except water - will be allowed for the following 5 hours unless needed to correct hypoglycemia.
The participants will be instructed to avoid exercise the day before and on the same day of the experimental session. Capillary blood glucose level measured by a calibrated finger-prick blood glucose meter before the meal , immediately prior to exercise (30 minutes before the start of the meal), after the exercise (60 minutes after the start of the meal) and then every hour throughout the 6-hour postprandial period.
The blood glucose excursion throughout the 6-hour postprandial period is the primary outcome measure of the study. Secondary outcome measures included the time to peak and time to lowest blood glucose levels, blood glucose area under the curve (AUC) and the frequency of postprandial hypoglycemia among the study participants.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Aerobic and resistance exercises
- 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.
Aerobic and resistance exercisesBehavioural
- Aerobic exercise session: A 30-minutes of brisk walking exercise on an indoor track without speed walking or running .
- Resistant exercise session: A 30-minutes of resistance exercise using rubber bands including warm-up and cool-down periods. Rubber band exercises are composed of seven exercises: squat, leg extension, pull apart, seated row, standing biceps curl, overhead press and lateral raise. Each exercise consists of three sets of 10 repetitions with 1 minute rest between each exercise set.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents aged 10-18 years, diagnosed with T1DM for at least 1 year | Experimental | Each participant will be assigned to perform either the aerobic or the resistance exercise sessions following the lunch meal in a random sequence by the withdrawal of a sealed envelope containing a paper with a written random sequence of the two exercise sessions. The envelope will be withdrawn randomly and opened immediately before the first exercise session. The other type of exercise session will be performed after 48 hours. Receives: Behavioral: Aerobic and resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood glucose excursion throughout the 6-hour postprandial period.
Capillary blood glucose level measured by a calibrated finger-prick blood glucose meter.
Measured: Before the meal, immediately prior to exercise (30 minutes after the start of the meal), after the exercise (60 minutes after the start of the meal) and then every hour throughout the 6-hour postprandial period.
Secondary outcomes (1)
Blood glucose area under the curve (AUC)
Capillary blood glucose level measured by a calibrated finger-prick blood glucose meter.
Measured: 6 hours after the meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Jan 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will be assigned to perform either the aerobic or the resistance exercise sessions following the lunch meal in a random sequence by the withdrawal of a sealed envelope containing a paper with a written random sequence of the two exercise sessions. The envelope will be withdrawn randomly and opened immediately before the first exercise session. The other type of exercise session will be performed after 48 hours.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Safwat Ibrahim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680557
- Sponsor's protocol ID
- Soh-Med-15-10__2MS
- Status last verified
- Dec 2025
- First submitted
- 2 Nov 2024
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Types of Exercises on Postprandial Blood Glucose Levels in Children and Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06680557
- Acronym / sponsor ID
- Soh-Med-15-10__2MS
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 8 Nov 2024 (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 aimed to assess the effect of aerobic and resistance exercise on postprandial blood glucose levels in children and adolescents aged 10 - 18 years, diagnosed with type 1 diabetes mellitus (T1DM) for at least 1 year, attending the Pediatric diabetes clinic at Sohag University Hospital and using multiple daily insulin (MDI) regimen.
Detailed description
The participants will be admitted at the pediatric department, Sohag University Hospital for 1 week. Full history taking, thorough clinical examination, review of participants' medical files and assessment of their basal insulin doses ,Insulin to carbohydrate ratio(ICR) and Insulin sensitivity factor (ISF) will be done if required. During hospitalization, the study participants will be familiarized with the types of the exercises used and how to perform each exercise carefully with the help of an exercise specialist before the experimental sessions. The pre-exercise lunch meal will be standardized to provide 30% of the total daily caloric requirement for the study participant (50% carbohydrate, 30% fat and 20% protein). The meal will consist of rice, chicken breast, vegetables and fruits. The Lunch meals will be consumed at the pediatric department, Sohag university hospital at 2 PM. The meal will be consumed within 20 minutes. Each participant will be assigned to perform either the aerobic or the resistance exercise sessions following the lunch meal in a random sequence by the withdrawal of a sealed envelope containing a paper with a written random sequence of the two exercise sessions. The envelope will be withdrawn randomly and opened immediately before the first exercise session. The other type of exercise session will be performed after 48 hours.
Participants will wear a bracelet heart rate monitor during the exercise sessions. Each participant will perform each of the following 2 exercise sessions 30 minutes after the lunch meal in a random sequence with 48-hour period between the 2 exercise sessions
- Aerobic exercise session: A 30-minutes of brisk walking exercise on an indoor track without speed walking or running .
- Resistant exercise session: A 30-minutes of resistance exercise using rubber bands including warm-up and cool-down periods. Rubber band exercises are composed of seven exercises: squat, leg extension, pull apart, seated row, standing biceps curl, overhead press and lateral raise. Each exercise consists of three sets of 10 repetitions with 1 minute rest between each exercise set.
Following the exercise session, participants will be allowed to perform only sedentary activities. No food or drink - except water - will be allowed for the following 5 hours unless needed to correct hypoglycemia.
The participants will be instructed to avoid exercise the day before and on the same day of the experimental session. Capillary blood glucose level measured by a calibrated finger-prick blood glucose meter before the meal , immediately prior to exercise (30 minutes before the start of the meal), after the exercise (60 minutes after the start of the meal) and then every hour throughout the 6-hour postprandial period.
The blood glucose excursion throughout the 6-hour postprandial period is the primary outcome measure of the study. Secondary outcome measures included the time to peak and time to lowest blood glucose levels, blood glucose area under the curve (AUC) and the frequency of postprandial hypoglycemia among the study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will be assigned to perform either the aerobic or the resistance exercise sessions following the lunch meal in a random sequence by the withdrawal of a sealed envelope containing a paper with a written random sequence of the two exercise sessions. The envelope will be withdrawn randomly and opened immediately before the first exercise session. The other type of exercise session will be performed after 48 hours.
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents aged 10-18 years, diagnosed with T1DM for at least 1 year | Experimental | Behavioral: Aerobic and resistance exercisesEach participant will be assigned to perform either the aerobic or the resistance exercise sessions following the lunch meal in a random sequence by the withdrawal of a sealed envelope containing a paper with a written random sequence of the two exercise sessions. The envelope will be withdrawn randomly and opened immediately before the first exercise session. The other type of exercise session will be performed after 48 hours. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year
Key exclusion criteria (1 listed)
- Children and adolescents with associated diseases such as autoimmune hypothyroidism or celiac disease and those with diabetes-related complications such as diabetic neuropathy, retinopathy or nephropathy
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 |
|---|---|---|
| Aerobic and resistance exercises* Aerobic exercise session: A 30-minutes of brisk walking exercise on an indoor track without speed walking or running . * Resistant exercise session: A 30-minutes of resistance exercise using rubber bands including warm-up and cool-down periods. Rubber band exercises are composed of seven exercises: squat, leg extension, pull apart, seated row, standing biceps curl, overhead press and lateral raise. Each exercise consists of three sets of 10 repetitions with 1 minute rest between each exercise set. | Behavioural | Children and adolescents aged 10-18 years, diagnosed with T1DM for at least 1 year |
Primary outcome
The blood glucose excursion throughout the 6-hour postprandial period.
Time frame: Before the meal, immediately prior to exercise (30 minutes after the start of the meal), after the exercise (60 minutes after the start of the meal) and then every hour throughout the 6-hour postprandial period.
Capillary blood glucose level measured by a calibrated finger-prick blood glucose meter.
1 secondary outcome
Blood glucose area under the curve (AUC)
Time frame: 6 hours after the meal.
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 23 Dec 2025.
- 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 Aerobic and resistance exercises in people with Diabetes Mellitus, Type 1, run by Sohag University at 1 site in Egypt.
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 1 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 23 Dec 2025. 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 Egypt. 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?
The blood glucose excursion throughout the 6-hour postprandial period. (time frame: Before the meal, immediately prior to exercise (30 minutes after the start of the meal), after the exercise (60 minutes after the start of the meal) and then every hour throughout the 6-hour postprandial period.). 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 23 Dec 2025.