Effect of Metformin in Children With Type 1 Diabetes

• Status: Completed
• Trial end date: 2021-01-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Patients with type 1 diabetes mellitus (5 years duration at least) and with micro-vascular complications.

• Patients on regular visits to clinic.

• Patients on regular insulin therapy.

Exclusion Criteria:

• Any clinical evidence of infection, hematological diseases, tumors, liver dysfunction, urinary tract disorders, connective tissue disease, or other autoimmune diseases.