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The Effect of Verapamil on beta cell function in adolescents and adults with cystic fibrosis-related dysglycemia

Award Number: R01DK147006
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/31/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2029

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The Effect of Verapamil on beta cell function in adolescents and adults with cystic fibrosis-related dysglycemia - ABSTRACT Cystic fibrosis-related diabetes (CFRD) is increasingly prevalent comorbidity in people with cystic fibrosis (PwCF). CFRD and its precursor state, abnormal glucose tolerance (AGT), are associated with progressive pulmonary decline and nutritional deterioration. Insulin is the mainstay of treatment for CFRD and is known to improve long-term clinical outcomes. However no therapies, including insulin, currently exist to improve clinical outcomes in AGT, limit beta cell dysfunction, or halt progression from AGT to CFRD. Oxidative stress is known to contribute to both type 1 (T1D) and type 2 diabetes mellitus (T2D). Thioredoxin- interacting protein (TXNIP), a key regulator of oxidative stress, is upregulated in hyperglycemic states and contributes to beta cell apoptosis and impaired insulin secretion. Verapamil, a widely used calcium channel blocker, downregulates TXNIP and has shown promise in preserving beta cell function in T1D and T2D. Emerging data implicates oxidative stress as a central component of cystic fibrosis pathology, including within the CF pancreatic islets. Oxidative stress in PwCF is likely exacerbated by chronic inflammation, impaired antioxidant defenses, and CFTR-related cellular dysfunction. The effects of verapamil on beta cell function and dysglycemia in people with CF-related dysglycemia are currently unknown. We propose a pilot pre/post interventional clinical trial to assess the efficacy and safety of verapamil in 30 adolescents (>14 years) and adults with CF and AGT or early CFRD (not yet on insulin). Aim 1 will determine whether verapamil (a) improves beta cell function, measured by mixed meal tolerance test (MMTT)-stimulated C-peptide area under the curve (AUC), and (b) reduces dysglycemia, assessed via continuous glucose monitoring (CGM), over a 6-month treatment period. Aim 2 will evaluate the safety, tolerability, and adherence to verapamil in this population. We hypothesize that verapamil will improve beta cell function and glycemic control, while demonstrating a favorable safety profile. This study will address a pressing unmet need in the management of AGT and early CFRD and provide further insight into the mechanism of CF-related dysglycemia. This proposal has the potential to transform the management of AGT and CFRD through a targeted, low risk, low-cost intervention aimed at preserving beta cell function and improving dysglycemia, providing key preliminary data to inform a larger phase 3 trial in this patient population.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $343,940 )
2026	2026	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/31/2026	NEW	$343,940
														Subtotal = $343,940

Grand Total All Awards = $343,940

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The Effect of Verapamil on beta cell function in adolescents and adults with cystic fibrosis-related dysglycemia

Award Number: R01DK147006

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/31/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2029

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