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
This trial does not accept healthy volunteersQualifiers
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 population
Individuals with Cystic Fibrosis related Diabetes (CFRD) Subjects will be recruited from the UAB Health System. Primary locations for recruitment will include the CF center and pulmonary clinics and endocrinology clinics. Dr. Solomon is the Associate Director of the CF center and the Co-Director of the Clinical Research Unit. He will work with the clinical provider team of the adult CF clinic to find eligible patients. All physical recruitment locations are within 5-30 minutes walking/driving distance from the UAB Clinical Research Unit (CRU). Dr. A. Basu, is Director of the Diabetes Technology Clinic at UAB and he sees many of these patients for diabetes care; we also have open communication with the endocrinology and primary care clinics at UAB, where we have had success in the past recruiting for previous and current ongoing studies. Electronically, we will recruit through the UAB Hospital electronic medical record (EMR) system, and UAB internet p
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: CFRD F508del +ETI
Group B: CFRD-ETI
Trial outcomes
Primary outcomes
1
Disposition Index in CFRD
Disposition Index (DI - β-cell responsivity appropriate to the degree of insulin resistance) is higher in CFRDF508del+ETI when compared to CFRD with a mutation not eligible to be on ETI (CFRD-ETI).
Time frame
Day 1 During the Mixed meal testSecondary outcomes
1
Post prandial glucose turnover
Post prandial glucose turnover is improved in CFRDF508del+ETI when compared to CFRD with a mutation not eligible to be on ETI (CFRD-ETI).
Time frame
Day 1 During the mixed meal testSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov