Cardiopulmonary Fitness and Health-Related Quality of Life in Children and Adolescents With Type 1 Diabetes (FIT-T1D) (FIT-T1D)

July 22, 2026 updated by: Institut Saint Pierre

Cardiopulmonary Fitness and Health-Related Quality of Life in Children and Adolescents With Type 1 Diabetes: The Prospective Multicenter Controlled FIT-T1D Study

Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk.

Our previous studies have demonstrated impaired exercise capacity and reduced quality of life, associated with physical deconditioning and increased sedentary behavior in children and adolescents with other chronic diseases.

This study aims to evaluate cardiopulmonary fitness, physical activity and health-related quality of life in children with type 1 diabetes aged 6 - 17 years and to compare these outcomes with healthy peers. We also aim to evaluate the parameters associated with cardiopulmonary fitness in this population.

Study Overview

Status

Completed

Conditions

Detailed Description

Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk.

Our previous studies have demonstrated impaired exercise capacity and reduced quality of life, associated with physical deconditioning and increased sedentary behavior in children and adolescents with other chronic diseases.

This study aims to evaluate cardiopulmonary fitness, physical activity and health-related quality of life in children with type 1 diabetes aged 6 - 17 years and to compare these outcomes with healthy peers. We also aim to evaluate the parameters associated with cardiopulmonary fitness in this population.

Primary outcome: The primary outcome will be the VO2max, assessed by a standardized CPET on cycloergometer. These results will be expressed in Z-score, using contemporary Z-score values in pediatric population.

Secondary Outcomes :

  • Others functional parameters of the CPET will be analyzed (maximum heart rate, ventilatory anaerobic threshold, ventilatory efficiency, oxygen pulse, maximal power, respiratory exchange ratio, respiratory reserve) which enable a precise understanding of adaptations and potential limiting factors.
  • Health Related Quality of Life will be assessed using valeted scores in the pediatric population (PedsQL and PedsQL proxy)
  • Muscular strength of superior limbs will be measured using a hand dynamometer (Jamar Handgrip). Muscular strength of inferior limbs will be measured using the Easyforce dynamometer. These values will be compared to references values published in pediatric population.
  • Level of Physical Activity will be assessed with two different tools. Measurement of the Metabolic Equivalent of Task (MET), a validated method for measuring physical activity intensity and energy expenditure will be assessed using an activity monitor (ActiGraph 3GTX®) worn for 7 days. Patients will fill a physical activity and sedentarily related score (CAPAS-Q). The two dimensions (physical activities and sedentary behaviors) appear to correlate with accelerometry measurements.
  • An information sheet filled by patients will permit us to collect diabetes treatment's modality, sociodemographic factors and to assess diabetes control (HbA1c, TIR, variability of glycemia, time in hypoglycemia)

Based on our previous similar work and studies that have measured VO2max in young diabetics, we expect to observe a difference of 3.5mL/kg/min between the cohort's VO2max and our published reference values (mean sex-adjusted norm 43.5±7.5 mL/ kg/min). With an α-risk of 5%, power of 90% and 10% missing data on the primary endpoint, we plan to include a total of 214 subjects, including 107 patients and 107 controls.

Control population has already been recruited and studied in one of our previous studies from 2021 to 2023 assessing the same outcomes.

Study Type

Observational

Enrollment (Actual)

214

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

  • France
      • Palavas-les-Flots, France, 34250
        • Institut Saint Pierre

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

Sampling Method

Non-Probability Sample

Study Population

Patient aged from 6 to 17 years with a type 1 diabetes

Description

Inclusion Criteria:

  • Patient aged from 6 to 17 years with a type 1 diabetes (diagnosed at least 1 month before)

Exclusion Criteria:

  • Patient with a congenital heart disease or any significative comorbidity that could reduce functional capacities
  • Patient with a contraindication to the CPET

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

Cohorts and Interventions

Group / Cohort
Healthy Children
Children with type 1 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2max
Time Frame: Measured at the baseline study visit (single cross-sectional assessment)
Maximum oxygen uptake measured during a cardiopulmonary exercise test and expressed using contemporary pediatric reference values (Z-score)
Measured at the baseline study visit (single cross-sectional assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional parameters of CPET
Time Frame: Measured at the baseline study visit (single cross-sectional assessment)
Maximum heart rate, ventilatory anaerobic threshold, ventilatory efficiency, oxygen pulse, maximal power, respiratory exchange ratio, respiratory reserve expressed expressed using contemporary pediatric reference values (Z-score)
Measured at the baseline study visit (single cross-sectional assessment)
Health-Related Quality of Life
Time Frame: Measured at the baseline study visit (single cross-sectional assessment)
Health Related Quality of Life will be assessed using valited scores in the pediatric population (PedsQL and PedsQL proxy)
Measured at the baseline study visit (single cross-sectional assessment)
Muscular Strength
Time Frame: Measured at the baseline study visit (single cross-sectional assessment)
Muscular strength in superior limbs will be measured using a hand dynamometer (Jamar Handgrip). Muscular strength of inferior limbs will be measured using a knee extensor dynamometer (EasyForce). These values will be compared to references values published in pediatric population.
Measured at the baseline study visit (single cross-sectional assessment)
Level of Physical Activity
Time Frame: - From the baseline study yo seven days later for the dynamometer - Measured at the baseline study visit (single cross-sectional assessment) for the score

Level of Physical Activity will be assessed with two different tools :

  • Measurement of the Metabolic Equivalent of Task (MET), a validated method for measuring physical activity intensity and energy expenditure will be assessed using an activity monitor (ActiGraph 3GTX®) worn for 7 days.
  • Patients will fill a physical activity and sedentarily related score (CAPAS-Q). The two dimensions (physical activities and sedentary behaviors) appear to correlate with accelerometry measurements
- From the baseline study yo seven days later for the dynamometer - Measured at the baseline study visit (single cross-sectional assessment) for the score

Collaborators and Investigators

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

Sponsor

Institut Saint Pierre

Investigators

  • Principal Investigator: Sophie Guillaumont, MD, Institut Saint Pierre - Palavas
  • Study Chair: Pascal Amedro, PHD, eart & Lung Center - Children's National Hospital - Washington
  • Study Chair: Fabienne Dalla-Valle, MD, Institut Saint Pierre - Palavas
  • Study Chair: Marion Audie, MD, Hôpital Haut-Lévêque - CHU Bordeaux
  • Study Chair: Caroline Neyraud, MD, Hôpital Haut Lévêque - CHU Bordeaux
  • Study Chair: Pascal Barat, PHD, Hôpital Haut Lévêque - CHU Bordeaux
  • Study Chair: Victor Pommier, MD, CHU Saint Denis - La Réunion
  • Study Chair: Patricia Kherchiche, MD, CHU Saint Denis - La Réunion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 4, 2025

Primary Completion (Actual)

July 1, 2026

Study Completion (Actual)

July 1, 2026

Study Registration Dates

First Submitted

July 22, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01098-41 (Other Identifier: Institut Saint Pierre)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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