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

NCT ID: NCT06803446

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2026-12-19

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

Detailed Description

Single-center, randomized, controlled study in adolescents living with type 1 diabetes. This study aims to evaluate the effect of exercise timing (morning vs. afternoon) and exercise type (continuous vs. intermittent) on blood glucose levels during and after exercise, as well as to assess the effect of exercise timing (morning vs. afternoon) and type of exercise (continuous vs. intermittent) on blood glucose during and after exercise

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Continuous - morning

Continuous exercise on ergocycle in the morning

Group Type: EXPERIMENTAL

No interventions assigned to this group

Continuous - afternoon

Continuous exercise on ergocycle in the afternoon

Group Type: EXPERIMENTAL

physical test

Intervention Type: OTHER

continuous and intermittent exercise on cycloergometer

Intermittent - morning

Intermittent exercise on ergocycle in the morning

Group Type: EXPERIMENTAL

No interventions assigned to this group

Intermittent - afternoon

Intermittent exercice on ergocycle in the afternoon

Group Type: EXPERIMENTAL

physical test

Intervention Type: OTHER

continuous and intermittent exercise on cycloergometer

Interventions

physical test

continuous and intermittent exercise on cycloergometer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurasport

Loos, Nord, France

Site Status: RECRUITING

Countries

France

Facility Contacts

Sémah TAGOUGUI

Role: primary

semah.tagougui@univ-lille.fr

+33 (0)3 74 00 82 00

Other Identifiers

D2024-05

Identifier Type: -

Identifier Source: org_study_id