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临床试验/NCT03554668
NCT03554668已完成不适用

The Relation Between Acute Changes in the Systemic Inflammatory Response, Thiamine and Magnesium Concentrations and Transketolase Activity After Elective Knee Arthroplasty.

Glasgow Royal Infirmary1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
erythrocyte transketolase activity

研究概览

简要总结

We wish to determine to what extent magnesium, thiamine and transketolase activity are affected by the Systemic Inflammatory Response (SIR). The knee arthroplasty model affords the ideal study design, as surgery generates an inflammatory response.

Blood samples are drawn preoperatively and for up to four days post operatively, and again at three months post-operation.

详细描述

Thiamine and magnesium play a critical role in glucose metabolism and deficiency results in the accumulation of anaerobic metabolites including lactate (1-3).

Thiamine requires magnesium to be converted to its active form, thiamine pyrophosphate (TPP) (4). TPP also requires magnesium to achieve activation of TPP dependent enzymes during metabolism of glucose (5, 6). The 'gold standard' for the measurement of thiamine status is the measurement of Erythrocyte Transketolase Activity (ETKA)(4, 7-9), and this enzyme's activity is dependent on the presence both thiamine pyrophosphate and magnesium (8, 10). ETKA may therefore represent a 'functional marker' of magnesium status (7, 9, 11, 12).

Studies indicate that low plasma thiamine and magnesium are associated with a range of disease processes, many of which are inflammatory (13-17). Other lipid-soluble vitamins and minerals are known to decrease during the systemic inflammatory response (18, 19), however this relationship is not proven for magnesium. The systemic inflammatory response may therefore confound the interpretation of plasma thiamine and magnesium in the context of sepsis, surgery or autoimmune disease. Elective knee arthroplasty, provokes an inflammatory response and therefore provides an excellent controlled model for understanding the body's response to a systemic insult (19).

Obesity is reported to be associated with magnesium deficiency (17, 20). Intracellular magnesium plays a key role in regulating insulin action, insulin-mediated-glucose-uptake and vascular tone (21-23). Several epidemiologic studies have shown that adults and children consuming a western type diet are consuming 30 - 50% of the RDA for magnesium (24, 25). This deficiency appears to be predominantly subclinical and therefore not routinely investigated.

Obesity is also associated with thiamine and magnesium depletion (17, 20, 26, 27). Magnesium deficiency is also associated with a CRP rise (28-30). Thiamine status is proven to affect lactate concentrations in the blood (2, 3). Lactate accumulation is known to precede the onset of insulin resistance and be characteristically found in patients with obesity related diabetes (31-37).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing elective total knee replacement

排除标准

  • taking multivitamin

结局指标

主要结局

erythrocyte transketolase activity

时间窗: three months

blood sample

serum magnesium

时间窗: three months

blood sample

thiamine

时间窗: three months

blood sample

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Donogh Maguire

Emergency Medicine Clinical Researcher

Glasgow Royal Infirmary

研究点 (1)

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