Oral verapamil in newly diagnosed children and teens with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effect of once-daily oral verapamil versus placebo on pancreatic beta-cell reserve, glycemic metrics, and daily insulin requirements in children and adolescents aged 10 to 18 who were newly diagnosed with type 1 diabetes within the last six weeks. Participants must have multiple islet autoantibodies and be able to adhere to study procedures. Exclusion criteria include other autoimmune diseases, medications affecting glucose metabolism, significant cardiac issues, severe liver or kidney impairment, and current participation in another interventional trial. The study is led by Ain Shams University in Cairo, with verapamil as the active intervention and a placebo comparator across Phase 2 and Phase 3 settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Ain Shams University
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Nouran Salah, MD
• Email: nouranyousef@med.asu.edu.eg
• Phone: +201116603336

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.