Oral Verapamil Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes
NCT07804849
Summary
Type 1 diabetes (T1D) in children involves autoimmune destruction of pancreatic ß- cells, leading to insulin deficiency. Verapamil is an L-type calcium channel blocker that has been used for decades to treat hypertension and certain cardiac conditions. Recent research has revealed its potential as a ß- cell-protective agent. Hence this study will evaluate the effect of once-daily oral verapamil on pancreatic ß- cell reserve , glycemic metrics and daily insulin requirements in children and adolescents with T1D.
Eligibility
Inclusion Criteria: * Children and adolescents aged 10-18 years. * Newly diagnosed type 1 diabetes mellitus (within 6 weeks of diagnosis, defined as the day of starting insulin therapy). * Presence of at least two positive islet autoantibody (anti glutamic acid decarboxylase antibodies, anti- tyrosine phosphataseantibodies ,anti- zinc transporter 8 protein antibodies , or anti-insulin antibodies). * Ability to comply with study procedures. Exclusion Criteria: * Previous diagnosis of other endocrine disorders or autoimmune disorder (e.g. autoimmune thyroiditis). * Current or planned use of medications that might affect glucose metabolism (e.g., corticosteroids, immunomodulators). * Known allergy or intolerance to verapamil. * Cardiac conduction abnormalities, heart block, or significant cardiac disease. * Systolic or diastolic blood pressure \< 5th percentile for age and gender. * Severe hepatic or renal impairment. * Participation in another interventional clinical trial. * Inability to follow the protocol for any reason as determined by the investigator. * Elevated liver enzymes \>1.5 × upper limit of normal at screening
Conditions2
Interventions1
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NCT07804849