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Recruiting
NCT07804849
Oral Verapamil Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes
Conditions: Type 1 Diabetes Mellitus
Sex: All
Ages: 10 Years – 18 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 70
Sponsor: Ain Shams University
Location: Ain Shams University Cairo
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 Criteria
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
Source: ClinicalTrials.gov (NCT07804849). StuddyBuddy aggregates publicly available trial information.