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Recruiting NCT06803446

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

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: physical test.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: 10 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Other physical test
    continuous and intermittent exercise on cycloergometer

Primary outcome measures

  • Comparison of glycemic variation between the 4 conditions [Time frame: 1 year 10 months september 2026]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Eurasport — Loos

Identifiers

NCT: NCT06803446 · D2024-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗