NCT03112382已完成4 期
Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SLC30A8 rs13266634 polymorphism
研究概览
简要总结
Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Established diagnosis of type 2 diabetes mellitus.
- •Age between 20 and 64 years.
- •BMI < 40 kg/m
- •On fixed oral hypoglycemic dosage for at least 3 months.
- •Normal serum creatinine (0.5 to 1.3 mg/dL) with no clinical evidence suggestive kidney disease.
- •Normal liver function tests (ALT 7 to 55 U/L, and albumin ˃ 3.5 g/dL).
排除标准
- •Those diagnosed of osteomalacia, chronic alcoholics. Patients with type 1 Diabetes Mellitus.
- •Those who were taking multivitamin containing zinc or magnesium or any sort of mineral supplements in the previous three months or hormone replacement therapy (estrogen, progesterone) or chelating therapy such as penicillamine, or anticonvulsant (phenytoin, valproate).
- •Those with a history of recent surgery or with concurrent acute illness including infectious disease, trauma, inflammatory bowel disease, malignancy, and active immunological diseases, using corticosteroids.
- •Pregnant or intend to be pregnant for t least 3 months or lactating women.
- •Those who were receiving insulin preparations as a part of diabetes management.
研究组 & 干预措施
zinc supplement plus vitamin A and E
Active Comparator
patients will be receiving zinc supplement plus vitamin A and E for 3 months.
干预措施: zinc supplement plus vitamin A and E (Drug)
vitamin A and E
Active Comparator
patients will be receiving equivalent dose of vitamin A and E only for 3 months
干预措施: vitamin A and E (Drug)
结局指标
主要结局
SLC30A8 rs13266634 polymorphism
时间窗: one year
genetic screening of SLC30A8 : solute carrier family 30 member 8
serum zinc
时间窗: at base line
次要结局
- change from baseline in HbA1c at three months(base line and three months)
- serum Mg(baseline)
- change from baseline in fasting and 2hr post prandial blood glucose at three months(at base line and after three months)
- change from baseline in fasting serum insulin at three months(baseline and three months)
- creatinine level(baseline)
- serum Iron(baseline)
- change from baseline in total serum Calcium at three months(baseline and three months)
- change from baseline in lipid profile at three months(base line and three months)
- change from baseline in ALT level at three months(baseline and three months)
研究者
Eman Said
Assisstant lecturer
Cairo University
研究点 (1)
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