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Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

Information source: University of Maryland
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes

Intervention: Zinc acetate (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: University of Maryland

Official(s) and/or principal investigator(s):
Alan R Shuldiner, MD, Principal Investigator, Affiliation: University of Maryland, Baltimore County

Summary

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

Clinical Details

Official title: Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Change in acute insulin response from IVGTT.

Secondary outcome:

change in insulin sensitivity

change in disposition index

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

change in serum zinc

change in urinary zinc

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.

Eligibility

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Amish Research Clinic, Lancaster, Pennsylvania 17601, United States
Additional Information

Starting date: September 2009
Last updated: September 28, 2012

Page last updated: August 20, 2015

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