Cystic Fibrosis Clinical Trials

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Glucose Metabolism in CFRD: Exploring the Role of CFTR Modulators in Metabolic Dysfunction

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI). CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI) will be the control group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ Individuals who have at least one copy of the F508 deletion and are on ETI medications and individuals who have a different mutation and are not eligible for ETI medications

⁃ Age 21-75 years at time of consent

⁃ BMI 19-50 kg/m2 (In Asians BMI is \

• 2 points lower for comparison so it is 17-48 kg/m2)

⁃ Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men

⁃ HbA1c ≤ 11% lifestyle treatment or mono/combination therapy with oral hypoglycemic agents (e.g. metformin or sulphonylurea or SGLT2i) and/or insulin.

⁃ Willing to be at a stable weight for duration of the study.

⁃ An understanding of and willingness to follow the protocol and sign the informed consent

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Rita Basu, MD
rbasu@uabmc.edu
205-934-1200
Backup
Ananda Basu, MD
anandabasu@uabmc.edu
205-934-1202
Time Frame
Start Date: 2026-05-28
Estimated Completion Date: 2028-05-28
Participants
Target number of participants: 30
Treatments
CFRD F508del +ETI
CFRD with at least one copy of F508del currently on elexacaftor/tezacaftor/ivacaftor (CFRDF508del+ETI),
CFRD-ETI
CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov