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Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

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ClinicalTrials.gov Identifier: NCT00981448
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Alan Shuldiner, University of Maryland, College Park

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

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Zinc acetate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
Study Start Date : September 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


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 Name: Orazinc




Primary Outcome Measures :
  1. Change in acute insulin response from IVGTT. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981448


Locations
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United States, Pennsylvania
Amish Research Clinic
Lancaster, Pennsylvania, United States, 17601
Sponsors and Collaborators
University of Maryland, Baltimore
Johns Hopkins University
Investigators
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Principal Investigator: Alan R Shuldiner, MD University of Maryland, Baltimore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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, College Park
ClinicalTrials.gov Identifier: NCT00981448    
Other Study ID Numbers: HP-00040355
1KL2RR025006-01 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Keywords provided by Alan Shuldiner, University of Maryland, College Park:
zinc
diabetes
genetics
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Zinc
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances