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Zinc and Diabetes in Patients With Thalassemia: a Pilot Study

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ClinicalTrials.gov Identifier: NCT01772680
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Study Description
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Brief Summary:
The primary aim of this study is to measure zinc status and related proteins in patients with Thalassemia who have or do not have diabetes. The secondary aim will be to explore the effect of zinc supplementation on glucose metabolism in patients with thalassemia.

Condition or disease Intervention/treatment Phase
Thalassemia Dietary Supplement: Zinc Supplementation Not Applicable

Detailed Description:

Patients with Thalassemia major (Thal) require frequent blood transfusions and are at risk for iron overload. High tissue iron increases the risk of various endocrinopathies, including diabetes, as well as cardiovascular disease, and infections due to the formation of free radicals. This systemic condition of oxidative stress elicits an antioxidant response to reduce tissue damage. Zinc is an important component of that response because it can compete with iron for multiple cellular binding sites and, therefore, reduce the redox-cycling of iron and minimize iron-mediated oxidation of lipids, proteins, and DNA.

In Thal patients with chronic hepatic iron overload, tissue zinc redistribution is likely to be persistent. This could create an unbalanced tissue zinc distribution with excessive amounts in the liver and deficient levels in other tissues altering zinc-dependent functions, such as growth, skeletal development, immunity, and glucose regulation. There is a rich body of literature focused on the 'diabetogenic effects' of altered zinc status which will be reviewed herein. Our group has recently shown that supplementation with 25 mg/d of zinc can improve bone density in patients with Thal. This provides evidence for a functional zinc deficiency, which may also affect other whole body zinc functions, such as insulin secretion and glucose homeostasis.

Our hypothesis is that hepatic iron overload induces a sub-clinical inflammatory response that alters the expression of MT and zinc-transport proteins leading to hepatic zinc sequestration, and an associated zinc-depletion in other tissues. Marginal zinc depletion in turn leads to increased oxidative stress, cellular apoptosis and altered glucose homeostasis and insulin secretion. This proposal will focus on cross-sectional differences in markers of glucose homeostasis and zinc status in diabetic and non-diabetic Thal patients, combined with a short- term zinc supplementation to explore the effect on glucose and insulin homeostasis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Zinc and Diabetes in Patients With Thalassemia: a Pilot Study
Study Start Date : November 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zinc Supplementation
25 mg elemental Zinc as Zn sulfate in capsule form taken daily for 3 months
 Dietary Supplement: Zinc Supplementation
25 mg elemental zinc taken as zinc sulfate in capsule form taken daily for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Oral glucose Tolerance Test [ Time Frame: 3 months ]
    Effect of 3 months of zinc supplementation on oral glucose tolerance test results


Secondary Outcome Measures :
  1. Fructosamine [ Time Frame: 3 months ]
    Determine the effect of 3 months of zinc supplementation on fructosamine levels


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients diagnosed with transfusion dependent thalassemia
  • > 12 years of age

Exclusion Criteria (for both cross-sectional and interventional studies)

  • patients who are pregnant
  • patients who are on growth hormone therapy

Exclusion criteria (for intervention study only)

  • patients who currently have diabetes (therefore cannot have an oral glucose tolerance test)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772680


Locations
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United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
Investigators
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Principal Investigator: Ellen B Fung, PhD RD UCSF Benioff Children's Hospital Oakland
More Information
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Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT01772680    
Other Study ID Numbers: 2012-071
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Keywords provided by UCSF Benioff Children's Hospital Oakland:
Thalassemia
Diabetes
Zinc
Iron-Overload
Additional relevant MeSH terms:
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Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn