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临床试验/NCT01309620
NCT01309620已完成2 期

Does Zinc Supplementation Reduce the Extent of Oxidative Stress Damage in Diabetics? A Randomised Placebo-controlled Study.

National University Hospital, Singapore0 个研究点目标入组 40 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
40
主要终点
Markers of oxidative damage

研究概览

简要总结

Zinc supplementation reduces the extent of oxidative damage and improves vascular indices in type 2 diabetics

详细描述

Study participants

Forty male type 2 diabetics, recruited from the outpatient clinic at the National University Hospital, Singapore, will be randomized to receive two tablets of either 100 mg zinc gluconate (GNC, USA) or placebo (99% microcystalline cellulose, 1% magnesium stearate) per day for 3 months. Subjects aged 21 years and above who fulfilled the American Diabetes Association criteria for the diagnosis of type 2 diabetes mellitus will be included in this study. We will exclude those who: had consumed over-the counter or prescription drugs, vitamin/mineral supplements or traditional Chinese remedies, suffered acute infection less than 30-days prior to the start of the study, had been diagnosed with active neuropsychiatric disease or hematological diseases, had hemoglobin less than 10g/dL, had previous use of narcotic drugs or regular alcohol intake in excess of 14 units per week. Each participant will provide written informed consent prior to their participation in this study.

Supplementation and sampling of blood and urine

A hospital research pharmacist will be engaged to randomize, blind the assigned treatment groups and count the remaining tablets so as to assess compliance. Blood and spot urine samples will be taken following an 8-hour fast at baseline (before supplementation), days 3 and 7, months 1, 2 and 3 during supplementation and 1 month following the intake of zinc or placebo (washout). An aliquot of blood will be collected in plain or EDTA tubes for serum or plasma separation respectively.

Markers of oxidative damage

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Markers of oxidative damage

时间窗: Three months

Isoprostanes, HETEs, cholesterol oxidation products, neuroprostanes, allantoin

次要结局

  • Vascular indices(Three months)

研究者

申办方类型
Other

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