MedDataX Logo

Exercises on Children and Adolescents With Type 1 Diabetes Mellitus (T1DM)

NCT ID: NCT06680557

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 The envelope will be withdrawn randomly and opened immediately before the first exercise session.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

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Children and adolescents aged 10-18 years, diagnosed with T1DM for at least 1 year

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.

Group Type EXPERIMENTAL

Aerobic and resistance exercises

Intervention Type BEHAVIORAL

* 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children and adolescents aged 10 - 18 years, diagnosed with T1DM for at least 1 year

Exclusion Criteria

* 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marina Safwat Ibrahim

Pediatric resident at Sohag University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University

Sohag, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-15-10__2MS

Identifier Type: -

Identifier Source: org_study_id