Status:
COMPLETED
Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Diabetes
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.
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., lifesty...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00981448
Start Date
September 1 2009
End Date
April 1 2012
Last Update
January 20 2022
Active Locations (1)
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1
Amish Research Clinic
Lancaster, Pennsylvania, United States, 17601