Zinc and Diabetes in Patients With Thalassemia: a Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital & Research Center Oakland
Sponsor:
Information provided by (Responsible Party):
Ellen B. Fung, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01772680
First received: January 17, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Thalassemia
Dietary Supplement: Zinc Supplementation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Zinc and Diabetes in Patients With Thalassemia: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Oral glucose Tolerance Test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Effect of 3 months of zinc supplementation on oral glucose tolerance test results


Secondary Outcome Measures:
  • Fructosamine [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Determine the effect of 3 months of zinc supplementation on fructosamine levels


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772680

Contacts
Contact: Ellen B Fung, PhD RD 510-428-3885 ext 4939 efung@mail.cho.org

Locations
United States, California
Children's Hospital & Research Center Oakland Recruiting
Oakland, California, United States, 94609
Contact: Ellen B Fung, PhD RD    510-428-3885 ext 4939    efung@mail.cho.org   
Sub-Investigator: Ashutosh Lal, MD         
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Ellen B Fung, PhD RD Children's Hospital & Research Center Oakland
  More Information

No publications provided

Responsible Party: Ellen B. Fung, Associate Research Scientist, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01772680     History of Changes
Other Study ID Numbers: 2012-071
Study First Received: January 17, 2013
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
Thalassemia
Diabetes
Zinc
Iron-Overload

Additional relevant MeSH terms:
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014