Nutrigenomics of Zinc Supplementation in Insulin Secretion and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in acute insulin response from IVGTT.
研究概览
简要总结
The purpose of this study is to evaluate the effect of zinc supplementation on insulin secretion by genotype of SLC30A8.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 21-70 years
- •Amish decent
- •genotyping of rs13266634 of SLC30A8 gene
- •previously consented to contact for future studies and future use of DNA
排除标准
- •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
结局指标
主要结局
Change in acute insulin response from IVGTT.
时间窗: 14 days
次要结局
- change in disposition index(14 days)
- change in insulin sensitivity(14 days)
- change in serum zinc(14 days)
- self-report of history of symptoms of anemia or gastrointestinal symptoms during study(14 days)
- change in urinary zinc(14 days)
研究者
Alan Shuldiner
Associate Dean for Personalized Medicine; Director, Program in Personalized and Genomic Medicine; Head, Division of Endocrinology, Diabetes and Nutrition
University of Maryland, Baltimore