The Effect of Verapamil on Beta Cell Function in Adolescents and Adults With Cystic Fibrosis-related Dysglycemia
Rhode Island Hospital
Summary
We 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.
Description
Cystic fibrosis-related diabetes (CFRD) is one of the most common non-pulmonary complications of cystic fibrosis (CF) and is associated with reduced pulmonary function, worse nutritional status, earlier mortality, and impaired quality of life. Dysglycemia in CF typically begins with abnormal glucose tolerance (AGT), characterized by impaired first-phase insulin secretion and postprandial hyperglycemia, and may progress over time to CFRD. Insulin therapy is currently the only recommended treatment for CFRD; however, it adds substantial treatment burden to an already medically complex population…
Eligibility
- Age range
- 14+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 14 years and older 2. Genetically-confirmed diagnosis of cystic fibrosis 3. Clinical diagnosis of pancreatic insufficiency, defined as requiring pancreatic enzyme replacement therapy (PERT) 4. Diagnosis of AGT or CFRD within 3-months of study enrollment 1. AGT is defined as having either a OGTT 2-hour glucose \>140 mg/dL and \<200 mg/dL or OGTT 1-hour glucose \>200 mg/dL 2. CFRD is defined as having a fasting glucose \>126 mg/dL and/or OGTT 2-hour glucose \>200 mg/dL 5. Willing to attempt to maximize verapamil to the goal study dosage of 360 mg PO daily 6. If…
Interventions
- DrugVerapamil Hydrochloride
Verapamil 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.
Locations (2)
- Diabetes Research Center, Massachusetts General HospitalBoston, Massachusetts
- Rhode Island HospitalProvidence, Rhode Island