drugset / Trial / NCT04879511

Effect of Metformin in Children With Type 1 Diabetes

NCT04879511

Phase 2/3 Completed 80 enrolled Ain Shams University
RandomizedParallel-groupSingle-blindTreatment

Summary

Cardiovascular disease is the leading cause of mortality in type 1 diabetes mellitus (T1DM). Vascular dysfunction is an early and critical event in the development of cardiovascular disease. Children with T1DM have vascular dysfunction therefore early interventions to improve vascular health are essential to reduce cardiovascular mortality in T1DM. Metformin is an insulin sensitising agent which is known to improve vascular health outcomes in type 2 diabetes mellitus (T2DM) and other individuals with insulin resistance. It has been used safely in children and adolescents with T2DM for over 10 years. This study aims to assess the effect of metformin on vascular health in children with T1DM. This is the first study to study effect of metformin on circulating neuregulin-4 levels as a marker for subclinical atherosclerosis.

Timeline

Start
2018-02-10
Primary completion
2021-01-01
Completion
2021-01-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule Oral
Comparator Basal/bolus insulin Unknown

Indications

No indication recorded.