Effects of Circadian Rhythm on Glycemic Regulation During Continuous Moderate Exercise and Intense Intermittent Disease in Adolescents Living With Type 1 Diabetes

NCT06803446 | Recruiting

• 1 other identifier: D2024-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional research with minimal risks and constraints on the effects of circadian rhythm on glycemic regulation during intense moderate, continuous and intermittent exercise in adolescents living with type 1 diabetes

Conditions

Type 1 Diabetes

Keywords

adolescents; type 1 diabetes; glycemic regulation; circadian rhythm

Outcome Measures

Primary Outcomes (1)

• Comparison of glycemic variation between the 4 conditions

  Observation of time in target, time in hypoglycemia and time in hyperglycemia

  1 year 10 months september 2026

Study Arms (4)

Continuous - morning

EXPERIMENTAL

Continuous exercise on ergocycle in the morning

Continuous - afternoon

EXPERIMENTAL

Continuous exercise on ergocycle in the afternoon

Other: physical test

Intermittent - morning

EXPERIMENTAL

Intermittent exercise on ergocycle in the morning

Intermittent - afternoon

EXPERIMENTAL

Intermittent exercice on ergocycle in the afternoon

Other: physical test

Interventions

physical test OTHER

continuous and intermittent exercise on cycloergometer

Continuous - afternoon; Intermittent - afternoon

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged 10 to 16;
• Living with type 1 diabetes for at least 1 year with HbA1c less than or equal to 12%;
• Socially insured ;
• Having given their written consent to participate in the research, as well as that of their legal guardians;
• Willing to comply with all research procedures and duration.

You may not qualify if:

• Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate less than 40 ml/min), neuropathy or severe proliferative retinopathy as assessed by the investigator;
• Recent acute macrovascular event (\< 3 months), e.g. acute coronary syndrome or cardiac surgery;
• Abnormal blood picture and/or anemia;
• Current pregnancy;
• Other serious medical condition likely to interfere with study participation or ability to complete exercise periods in the judgment of the investigator (e.g., orthopedic limitation);
• Inability to receive informed information;
• Inability to participate in the entire study;
• Lack of social security coverage;
• Refusal to sign the consent form.

Sponsors & Collaborators

• Lille University: lead

Study Sites (1)

Eurasport

Loos, Nord, 59120, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to do a trial in blind or double blind because the moment of the day and the exercice modality can not be hidden, however the results analysis will be assessed in blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 randomized handovers performed (on different days with meal/snack)previous standardized: * Continuous exercise on ergocycle in the morning * Continuous exercise on ergocycle in the afternoon * Intermittent exercise on ergocycle in the morning * Intermittent exercice on ergocycle in the afternoon

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: December 18, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)