Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06331000
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-02-23
Brief Title:
Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
DIATRIM Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment on Glucose Tolerance Abnormalities in Adult Patients With Cystic Fibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIATRIM
Brief 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 patients 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None