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

Primary Purpose

Beta-thalassemia Major Complicated With Diabetes

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Zinc
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Beta-thalassemia Major Complicated With Diabetes focused on measuring Zinc, blood glucose, diabetes, beta thalassemia

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nancy Elbarbary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

intervention group

Control group

Arm Description

will receive zinc supplementation

Patients will receive placebo only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c%
changes in HbA1c% levels
fructosamine mg/dl
changes in fructosamine levels mg/dl

Full Information

First Posted
February 21, 2019
Last Updated
February 21, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03851055
Brief Title
Zinc Supplementation in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus
Official Title
Effect of Zinc Supplementation on Glucose Homeostasis in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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: Assess zinc status in patients with β-thalassemia major and diabetes mellitus and its relation to clinical and laboratory parameters of these patients. Effect of zinc supplementation on glucose homeostasis in patients with β-thalassemia major and diabetes mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta-thalassemia Major Complicated With Diabetes
Keywords
Zinc, blood glucose, diabetes, beta thalassemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
will receive zinc supplementation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will receive placebo only
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Description
One arm will receive Zinc Second arm will receive placebo
Primary Outcome Measure Information:
Title
Fasting blood glucose mg/dl
Description
the change in fasting blood glucose level after the 12 weeks of treatment in the intervention group when compared to the placebo group.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c%
Description
changes in HbA1c% levels
Time Frame
12 weeks
Title
fructosamine mg/dl
Description
changes in fructosamine levels mg/dl
Time Frame
12 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Nancy Elbarbary
City
Cairo
ZIP/Postal Code
11361
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patients data and identity are totally anonymous to the study group
Citations:
PubMed Identifier
16462713
Citation
Gamberini MR, Fortini M, De Sanctis V, Gilli G, Testa MR. Diabetes mellitus and impaired glucose tolerance in thalassaemia major: incidence, prevalence, risk factors and survival in patients followed in the Ferrara Center. Pediatr Endocrinol Rev. 2004 Dec;2 Suppl 2:285-91.
Results Reference
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PubMed Identifier
23137858
Citation
Capdor J, Foster M, Petocz P, Samman S. Zinc and glycemic control: a meta-analysis of randomised placebo controlled supplementation trials in humans. J Trace Elem Med Biol. 2013 Apr;27(2):137-42. doi: 10.1016/j.jtemb.2012.08.001. Epub 2012 Nov 6.
Results Reference
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PubMed Identifier
23945720
Citation
Fung EB, Kwiatkowski JL, Huang JN, Gildengorin G, King JC, Vichinsky EP. Zinc supplementation improves bone density in patients with thalassemia: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Oct;98(4):960-71. doi: 10.3945/ajcn.112.049221. Epub 2013 Aug 14.
Results Reference
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Zinc Supplementation in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus

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