Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)
ConditionCystic Fibrosis Related Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-75
SponsorUniversity of Alabama at Birmingham
About this trial
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 criteria
Qualifiers
Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)
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
Disqualifiers
Debilitating chronic disease
Anemia <10.0 gm/dL in females and <11.0 gm/dL in males
Symptoms of undiagnosed illness on history/exam
Abuse of alcohol or recreational drugs
Trial design
Treatments tested in this trial
- Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsSponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov