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CompletedNCT00981448Updated Jan 20, 2022

Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

An interventional study of Zinc acetate in Diabetes, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Non-randomized
Ages
21 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.

Read the 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.

02

Conditions studied

  • Diabetes

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Keywords

  • zinc
  • diabetes
  • genetics
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 57 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Zinc supplement

    Dietary Supplement: Zinc acetate

Interventions

  • Dietary supplementZinc acetate

    50mg of elemental zinc to be administered 2 times daily orally for 14 days.

    Also known as: Orazinc

06

What researchers measure

Primary outcomes

  1. Change in acute insulin response from IVGTT.

    Time frame: 14 days

Secondary outcomes

  1. change in insulin sensitivity

    Time frame: 14 days

  2. change in disposition index

    Time frame: 14 days

  3. self-report of history of symptoms of anemia or gastrointestinal symptoms during study

    Time frame: 14 days

  4. change in serum zinc

    Time frame: 14 days

  5. change in urinary zinc

    Time frame: 14 days

07

Study locations

1 site
  • Amish Research Clinic
    Lancaster, Pennsylvania 17601, United States
08

References and documents

Publications

  • Maruthur NM, Clark JM, Fu M, Linda Kao WH, Shuldiner AR. Effect of zinc supplementation on insulin secretion: interaction between zinc and SLC30A8 genotype in Old Order Amish. Diabetologia. 2015 Feb;58(2):295-303. doi: 10.1007/s00125-014-3419-1. Epub 2014 Oct 28. PubMed 25348609 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00981448
Lead sponsor
University of Maryland, Baltimore
Collaborators
Johns Hopkins University
Responsible party
Alan Shuldiner (Associate Dean for Personalized Medicine; Director, Program in Personalized and Genomic Medicine; Head, Division of Endocrinology, Diabetes and Nutrition, University of Maryland, Baltimore) — Principal investigator
First posted
Sep 22, 2009
Start date
Sep 2009
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Jan 20, 2022

Study contacts

Alan R Shuldiner, MD
principal investigator · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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