Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

January 4, 2022 updated by: Alan Shuldiner, University of Maryland, Baltimore
The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

As diabetes increases at an alarming rate, strategies for prevention of this disease must be developed. For a given individual, there are both biologic (e.g., genetic) and environmental (e.g., lifestyle) factors that comprise her individual risk of diabetes. Researchers can take advantage the accumulating knowledge of these individual factors to design individualized strategies for diabetes risk assessment and prevention. For example, a mutation in a particular gene, SLC30A8, which encodes a zinc transporter, has been shown to increase the risk of diabetes probably through impairment of insulin secretion. In the proposed research project, the investigators aim to conduct a pilot study to see the effect of zinc supplementation on insulin secretion in people with and without this genetic mutation to see if zinc can improve insulin secretion in those with the mutation. The results from this study will help the investigators to plan a larger, more definitive study to determine if zinc supplementation can be used to prevent or treat diabetes in those with this mutation in SLC30A8.

Study Type

Interventional

Enrollment (Actual)

57

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
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Amish Research Clinic

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

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 21-70 years
  • Amish decent
  • genotyping of rs13266634 of SLC30A8 gene
  • previously consented to contact for future studies and future use of DNA

Exclusion Criteria:

  • Subject is a first-degree relative of another subject with the same SLC30A8 genotype
  • diabetes mellitus (by history, treatment or random BG>200 mg;dl)
  • gastrointestinal disease causing nausea, vomiting, or diarrhea including inflammatory bowel disease by history.
  • rheumatoid arthritis by history
  • albumin < 3.5 g/dL
  • hemochromatosis by history
  • hematocrit <34%
  • liver disease by history
  • alanine aminotransferase or aspartate aminotransferase greater than 2.5 times normal
  • renal failure by history
  • estimated glomerular filtration rate < 60 mL/min by MDRD equation
  • use of thiazide diuretic and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation
  • use of systemic corticosteroid and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation
  • use of highly-active antiretroviral medications
  • use of antipsychotic medications
  • use of quinolone antibiotics
  • use of tetracycline antibiotic and unwilling to discontinue if deemed safe in the opinion of the treating physician and study physician for 1 week prior to protocol initiation
  • use of chelation therapy in the past month
  • unwilling to withdraw from supplements for 1 week prior to the study and throughout study
  • abnormal thyroid stimulating hormone (TSH) level
  • serious disease precluding participation
  • reported pregnancy or positive urine hCG test
  • cancer diagnosis in past 2 years
  • breastfeeding
  • use of denture adhesive

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc supplement
Dietary supplement: Zinc acetate
50mg of elemental zinc to be administered 2 times daily orally for 14 days.
Other Names:
  • Orazinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in acute insulin response from IVGTT.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
change in insulin sensitivity
Time Frame: 14 days
14 days
change in disposition index
Time Frame: 14 days
14 days
self-report of history of symptoms of anemia or gastrointestinal symptoms during study
Time Frame: 14 days
14 days
change in serum zinc
Time Frame: 14 days
14 days
change in urinary zinc
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

University of Maryland, Baltimore

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Alan R Shuldiner, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00040355
  • 1KL2RR025006-01 (U.S. NIH Grant/Contract)

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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