Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
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Purpose
The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.
| Condition | Intervention |
|---|---|
|
Diabetes |
Dietary Supplement: Zinc acetate |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes |
- Change in acute insulin response from IVGTT. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- change in insulin sensitivity [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- change in disposition index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- self-report of history of symptoms of anemia or gastrointestinal symptoms during study [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- change in serum zinc [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- change in urinary zinc [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Enrollment: | 57 |
| Study Start Date: | September 2009 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Zinc supplement |
Dietary Supplement: Zinc acetate
50mg of elemental zinc to be administered 2 times daily orally for 14 days.
Other Name: Orazinc
|
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| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Pennsylvania | |
| Amish Research Clinic | |
| Lancaster, Pennsylvania, United States, 17601 | |
| Principal Investigator: | Alan R Shuldiner, MD | University of Maryland, Baltimore County |
More Information
No publications provided
| 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 |
| ClinicalTrials.gov Identifier: | NCT00981448 History of Changes |
| Other Study ID Numbers: | HP-00040355, 1KL2RR025006-01 |
| Study First Received: | September 18, 2009 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Maryland:
|
zinc diabetes genetics |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Zinc |
Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013