Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

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

Detailed Description
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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.

Official Title
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Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Dietary Supplement: Zinc acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc supplement<br> | Dietary Supplement: Zinc acetate<br>* 50mg of elemental zinc to be administered 2 times daily orally for 14 days.<br>* Other names: Orazinc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acute insulin response from IVGTT. |  | 14 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc, diabetes, genetics