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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
active comparator
placebo comparator
Ain Shams University
Cairo, Egypt
RECRUITINGPeak stimulated serum C-peptide concentration after mixed meal tolerance test
Peak stimulated serum C-peptide concentration after mixed meal tolerance test at 6 months (24 weeks) compared to baseline.
Time frame: 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Safety of verapamil during 24 weeks
Time frame: 24 weeks
HbA1c
HbA1c after 24 weeks compared to baseline
Time frame: 24 weeks
continuous glucose monitoring metrics (time in range) using freestyle libre2 plus CGM
Time in range using freestyle libre2 plus CGM at 24 weeks compared to baseline
Time frame: 24 weeks
coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM
CGM coefficient of variation at 24 weeks compared to baseline using freestyle libre 2 CGM
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.