Zinc and Diabetes in Patients With Thalassemia: a Pilot Study

November 20, 2020 updated by: UCSF Benioff Children's Hospital Oakland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
        • Children's Hospital & Research Center Oakland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral glucose Tolerance Test
Time Frame: 3 months
Effect of 3 months of zinc supplementation on oral glucose tolerance test results
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fructosamine
Time Frame: 3 months
Determine the effect of 3 months of zinc supplementation on fructosamine levels
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCSF Benioff Children's Hospital Oakland

Investigators

  • Principal Investigator: Ellen B Fung, PhD RD, UCSF Benioff Children's Hospital Oakland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (ESTIMATE)

January 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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