Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years with a prior diagnosis of CF.
Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor or vanzacaftor/tezacaftor/deutivacaftor for 30 days prior to day 0
Insulin use
Hemoglobin A1C >6.5%
Disqualifiers
Prior lung or liver transplant
Use of supplemental oxygen
BMI <18
CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
Trial design
Design model
Single group
Treatments tested in this trial
Metformin Hydrochloride
Drug1000 mg twice daily
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Metformin dose regimen AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in BK channel gene expression
Levels of LRRC26 (big potassium channel regulatory subunit) mRNA will be measured by polymerase chain reaction from nasal cells acquired via brushing
Time frame
Baseline through week 14 of metformin treatmentSecondary outcomes
1
Change in BK function, as measured by nasal potential difference testing
Nasal potential difference testing measures direct BK current in the nasal epithelium, with greater current indicating greater BK function
Time frame
Baseline through week 14 of metformin treatment2
Change in receptor for receptor for advanced glycation end products (RAGE) gene expression
Levels of RAGE mRNA will be measured by polymerase chain reaction from nasal cells acquired via brushing
Time frame
Baseline through week 14 of metformin treatment3
Change in advanced glycation end products (AGE)
Plasma levels of AGE, receptor for AGE (RAGE), soluble RAGE and S100A12 will be quantified by ELISA
Time frame
Baseline through week 14 of metformin treatment4
Change in sweat chloride
Measured as a secondary marker of CFTR function, with lower levels indicating greater CFTR function
Time frame
Baseline through week 14 of metformin treatmentSponsors and contacts
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Source ClinicalTrials.gov