Effects of Circadian Rhythm on Glycemic Regulation During Continuous Moderate Exercise and Intense Intermittent Disease in Adolescents Living With Type 1 Diabetes (CHRONODIAB1)

September 3, 2025 updated by: Lille University

Effets du Rythme Circadien Sur la régulation glycémique Lors d'Exercices modérés Continus et Intermittents Intenses Chez Des Adolescents Vivant Avec le diabète de Type 1

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous - morning
Continuous exercise on ergocycle in the morning
Other: physical test
continuous and intermittent exercise on cycloergometer
Experimental: Continuous - afternoon
Continuous exercise on ergocycle in the afternoon
Other: physical test
continuous and intermittent exercise on cycloergometer
Experimental: Intermittent - morning
Intermittent exercise on ergocycle in the morning
Other: physical test
continuous and intermittent exercise on cycloergometer
Experimental: Intermittent - afternoon
Intermittent exercice on ergocycle in the afternoon
Other: physical test
continuous and intermittent exercise on cycloergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of glycemic variation between the 4 conditions
Time Frame: 1 year 10 months september 2026
Observation of time in target, time in hypoglycemia and time in hyperglycemia
1 year 10 months september 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 19, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2024-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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