Verapamil Effect in Cystic Fibrosis-related Dysglycemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorRhode Island Hospital
About this trial
The investigators are conducting a pilot open-label pre/post interventional trial in adolescents and adults with cystic fibrosis (CF) and abnormal glucose tolerance or early CF-related diabetes mellitus (CFRD) to assess the safety and efficacy of verapamil on beta cell function and dysglycemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 14 years and older
Genetically-confirmed diagnosis of cystic fibrosis
Clinical diagnosis of pancreatic insufficiency, defined as requiring pancreatic enzyme replacement therapy (PERT)
Diagnosis of AGT or CFRD within 3-months of study enrollment
Disqualifiers
Severe lung disease indicated by forced expiratory volume in 1 second (FEV1) <50% predicted on most recent spirometry testing
Body mass index (BMI) <18 kg/m2
Weight <50 kg
Current or planned pregnancy within the next 6 months
Trial design
Design model
Single group
Treatments tested in this trial
Verapamil Hydrochloride
DrugVerapamil extended release (ER) will be initiated at a dose of 120mg daily and up-titrated over six weeks to target dose of 360mg daily as tolerated.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in 30-minute C-peptide area under the curve after mixed-meal tolerance test
laboratory test, measured in ng/mL
Time frame
Baseline, 6 monthsSecondary outcomes
1
Change in 180 minute C-peptide area under the curve after mixed-meal tolerance test
laboratory test, measured in ng/mL
Time frame
Baseline, 6 months2
Change in insulin level area under the curve after mixed-meal tolerance test
laboratory test, measured in microIU/mL
Time frame
Baseline, 6 months3
Change in proinsulin area under the curve after mixed-meal tolerance test
laboratory test, measured in pmol/L
Time frame
Baseline, 6 months4
Change in glucose area under the curve after mixed-meal tolerance test
laboratory test, measured in mg/dL
Time frame
Baseline, 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: