Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment

Cystic Fibrosis Clinical Trial

— DIATRIM  

Official title:

DIATRIM : Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment on Glucose Tolerance Abnormalities in Adult Patients With Cystic Fibrosis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06331000
• Other study ID #: 9248
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Strasbourg, France
• Contact: Laurence KESSLER, Pr
• Phone: (+33) 03 88 12 74 42
• Email: Laurence.Kessler[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with cystic fibrosis aged over 18
• Patients treated for 1 year by elexacaftortezacaftor-ivacaftor
• Normal tolerant or intolerant to glucose or presenting with cystic fibrosis related diabetes treated or not with insulin
• Patient who had a continuous glucose monitoring in the 6 months before and 6 months after one year of treatment with elexacaftor-tezacaftor-ivacaftor

Exclusion Criteria:

• Patient not eligible for triple CFTR modulator
• Patient intolerant to triple corrector
• Pregnant woman

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• elexacaftor-tezacaftor-ivacaftor treatment
Effect of one year elexacaftor-tezacaftor-ivacaftor treatment on glucose tolerance abnormalities in adult patients with cystic fibrosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		time in range of blood glucose variation >140 mg/dl one year before and one year after the begining of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Marker of metabolic status: HbA1c (mmol/l)		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Marker of metabolic status: HbA1c (%)		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Marker of metabolic status: C-Peptid (µg/L)		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Marker of metabolic status: C-Peptid (nmol/L)		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Markers of nutritional status: Evaluation of weight monitoring (kg)		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Markers of nutritional status: Body Mass Index (BMI)		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl)		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Assessment of respiratory function parameters : number of IV antibiotics		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Secondary	Number patients with severe hypoglycaemia and serious adverse events		One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment