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

Effect of Zinc Supplementation on Glucose Homeostasis in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03851055
Enrollment
80
Registered
2019-02-22
Start date
2017-08-01
Completion date
2018-08-28
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-thalassemia Major Complicated With Diabetes

Keywords

Zinc, blood glucose, diabetes, beta thalassemia

Brief 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.

Interventions

DRUGZinc

One arm will receive Zinc Second arm will receive placebo

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fasting blood glucose mg/dl12 weeksthe change in fasting blood glucose level after the 12 weeks of treatment in the intervention group when compared to the placebo group.

Secondary

MeasureTime frameDescription
HbA1c%12 weekschanges in HbA1c% levels
fructosamine mg/dl12 weekschanges in fructosamine levels mg/dl

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026