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NCT06331000Not yet recruiting

Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment

DIATRIM : Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment on Glucose Tolerance Abnormalities in Adult Patients With Cystic Fibrosis.
University Hospital, Strasbourg, FranceClinicalTrials.govdrug
Study focus
Disease/Condition
Cystic Fibrosis
Drug/Device/Intervention
elexacaftor-tezacaftor-ivacaftor treatment
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
University Hospital, Strasbourg, France
Timeline & enrollment
Phase
N/A
Start date
Mar 01, 2024
End date
Mar 01, 2025
Enrollment
100 participants
Primary outcome

Evaluate time in range of blood glucose variation 140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor

Summary

The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for
 people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic
 revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and
 the reduction of pulmonary exacerbations should have a considerable impact on the quality of
 life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance
 abnormalities are still very fragmentary. The investigators can think that their use, earlier
 and earlier in the history of the disease, will transform the evolutionary trajectories of
 patients on the respiratory, nutritional and metabolic levels.
 
 Diabetes represents a major challenge in the management of pwCF because it is a factor in
 morbidity and mortality at all stages of the disease, from children to patients with terminal
 respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance
 observed in childhood, before the stage of diabetes, are also associated with poor pulmonary
 and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin
 secretion. However, investigators do not currently know the impact of CFTRm in patients with
 very early glucose disorders or at the stage of diabetes treated with insulin. Recently
 continuous glucose measurement (CGM) devices represent very effective tools for assessing
 abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients
 treated with insulin.

ICD-10 classifications
Cystic fibrosisCystic fibrosis, unspecifiedCystic fibrosis with other manifestationsCystic fibrosis with pulmonary manifestationsCystic fibrosis with intestinal manifestations
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06331000
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06331000 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital, Strasbourg, France and is currently Not yet recruiting. The study focuses on Cystic Fibrosis. Target enrollment is 100 participants.

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