Verapamil Effect in Cystic Fibrosis-related Dysglycemia

Summary

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.

Timeline

Start

2026-08-01

Primary completion

2028-07-01

Completion

2028-08-31

Publications

• Background Forlenza GP, McVean J, Beck RW, Bauza C, Bailey R, Buckingham B, DiMeglio LA, Sherr JL, Clements M, Neyman A, Evans-Molina C, Sims EK, Messer LH, Ekhlaspour L, McDonough R, Van Name M, Rojas D, Beasley S, DuBose S, Kollman C, Moran A; CLVer Study Group. Effect of Verapamil on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2023 Mar 28;329(12):990-999. doi: 10.1001/jama.2023.2064.
• Background Ntimbane T, Krishnamoorthy P, Huot C, Legault L, Jacob SV, Brunet S, Levy E, Gueraud F, Lands LC, Comte B. Oxidative stress and cystic fibrosis-related diabetes: a pilot study in children. J Cyst Fibros. 2008 Sep;7(5):373-84. doi: 10.1016/j.jcf.2008.01.004. Epub 2008 Apr 16.
• Background Umashankar B, Eliasson L, Ooi CY, Kim KW, Shaw JAM, Waters SA. Beyond insulin: Unraveling the complex interplay of ER stress, oxidative damage, and CFTR modulation in CFRD. J Cyst Fibros. 2024 Sep;23(5):842-852. doi: 10.1016/j.jcf.2024.06.004. Epub 2024 Jun 18.
• Background Ode KL, Ballman M, Battezzati A, Brennan A, Chan CL, Hameed S, Ismail HM, Kelly A, Moran AM, Rabasa-Lhoret R, Saxby NA, Craig ME. ISPAD Clinical Practice Consensus Guidelines 2022: Management of cystic fibrosis-related diabetes in children and adolescents. Pediatr Diabetes. 2022 Dec;23(8):1212-1228. doi: 10.1111/pedi.13453. No abstract available.
• Background Norris AW, Ode KL, Merjaneh L, Sanda S, Yi Y, Sun X, Engelhardt JF, Hull RL. Survival in a bad neighborhood: pancreatic islets in cystic fibrosis. J Endocrinol. 2019 Apr;241(1):R35-R50. doi: 10.1530/JOE-18-0468.

Drugs

Indications