Zinc Supplementation in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus

• Status: Completed
• Trial end date: 2018-08-28
• Target enrollment: 0
• Participant gender: All

Summary

Beta-thalassemia represents a group of recessive inherited hemoglobin disorders characterized by reduced synthesis of β-globin chain. The homozygous state (β-thalassemia major) "TM" results in severe anemia, which needs regular blood transfusion . The life expectancy in patients with TM has increased due to therapeutically management, such as frequent transfusion, desferal administration and bone marrow transplantation. Diabetes is clinically characterized by hyperglycemia due to either low circulating concentrations of, or decreased sensitivity to, insulin. Patients with TM typically exhibit β-cell or insulin insufficiency, and may develop diabetes due to toxic levels of iron in their pancreas, one of the strongest predictors of β-cell destruction. By contrast, hyperinsulinemia, secondary to insulin resistance, with normal glucose tolerance has also been observed.

The pathogenic mechanisms leading from siderosis to diabetes are poorly understood.

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

Details

• Lead Sponsor: Ain Shams University
• Treatments: Zinc

Criteria

Inclusion Criteria:

• Patients with β-thalassemia major and diabetes confirmed by history, examination and investigation.

• Patients on regular visits to clinic.

• Age more than 10 years old.

Exclusion Criteria:

• Those who refused to lay informed consent.

• Those below age limit.

• Patients with other disorders that may affect glucose homeostasis rather than TM.

• Patients with autoimmune disease, collagen diseases, infections, tumors, hematological diseases other than Thalassemia major.