Zinc Supplementation in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus
Condition: Beta-thalassemia Major Complicated With Diabetes
MeSH terms: Thalassemia; beta-Thalassemia; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Zinc(Zn) is a critical trace element in human health. Zinc has a potential to be utilized for
      the treatment of type 2 diabetes; however, evidence suggests that the effect of Zn on type 2
      diabetes remains unclear. Up to 85% of the whole body Zn content is found in muscle and
      bones, with 11% in the skin and liver .Zn is an indispensable co-factor for more than 300
      enzymes involved in metabolism and also reportedly plays a role in aging, immune system,
      apoptosis, and oxidative stress.

      Although the effect of zinc supplementation in the improvement of oxidative stress is
      controversial, one of the causes that the oxidative stress is present in patients with type 2
      diabetes is the change in zinc metabolism. Recent studies have demonstrated that the
      islet-restricted zinc transporter, ZnT8 (SLC30A8), regulates insulin secretion and hepatic
      insulin clearance, suggesting that Zn is a key biological factor in glucose homeostasis and
      the risk of developing type 2 diabetes.

      In patients without thalassemia, there is a rich body of literature focused on the
      "diabetogenic effects" of altered zinc status.

      Zinc supplementation has even been suggested as an adjunct therapy in the management of
      non-thalassemia related diabetes .Functional zinc deficiency exists in a contemporary sample
      of healthy β-thalassemic patients. An estimated 20% to 30% of patients with β-thalassemia are
      zinc deficient. The high prevalence is thought to be related to a combination of increased
      urinary losses compounded by elevated requirements.

      Glucose homeostasis and its relation to Zinc status has not been widely studied especially in
      Egyptian children and adolescents with β-thalassemia major.

      The aim of this study is to:

        1. Assess zinc status in patients with β-thalassemia major and diabetes mellitus and its
           relation to clinical and laboratory parameters of these patients.

        2. Effect of zinc supplementation on glucose homeostasis in patients with β-thalassemia
           major and diabetes mellitus.
    

Intervention name(s): Zinc
Intervention type(s): Drug
Intervention description(s): One arm will receive Zinc Second arm will receive placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Zinc; blood glucose; diabetes; beta thalassemia