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Completed

NCT Number: NCT00981448

Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

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

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amish Research Clinic

Lancaster, Pennsylvania, 17601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc acetate

Dietary Supplement

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

Other names: Orazinc

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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Johns Hopkins University

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2009
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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