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

NCT06680557 | Completed

• 1 other identifier: Soh-Med-15-10__2MS
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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 insulin (MDI) regimen.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• The blood glucose excursion throughout the 6-hour postprandial period.

  Capillary blood glucose level measured by a calibrated finger-prick blood glucose meter.

  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)

  6 hours after the meal.

Study Arms (1)

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 The envelope will be withdrawn randomly and opened immediately before the first exercise session.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

Behavioral: Aerobic and resistance exercises

Interventions

Aerobic and resistance exercises 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.

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

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric resident at Sohag University Hospital

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 8, 2024
• Study Start: January 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

EG (1)