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临床试验/NCT03188757
NCT03188757已完成不适用

The Influence of Acute Hyperglycaemia on Oxidative Stress, Inflammation, Neurochemical Profile in Brain and Executive Functions of Adolescents With Type 1 Diabetes Mellitus

University of Ljubljana, Faculty of Medicine2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
prolonged reaction time

研究概览

简要总结

The study is going to include 20 adolescents, 5-10 years after onset of T1D, aged 12-20 years, on insulin pump. The participants are going to have MRI of the head in euglycaemic and hyperglycaemic state. During both MRI, the participants are going to preform Flanker test, Tower of London test and Spatial memory test. The investigators are going to evaluate the response of inflammation markers and oxidative stress marekers in blood during hypreglycaemia.

详细描述

The study is going to include 20 patientswith T1D. The group of patients is going to be homogeneous. The inclusion criteria are going to be: duration of T1D approximately 5 - 10 years, age between 10 and 24 years, without associated clinical complications of T1D, similar value of HbA1c and BMI within the normal range (depending on the percentile for age and sex), treatment with an insulin pump. Only the patients who are going to give written consent to participate in the form "Declaration of conscious and free consent" are going to be included.

All selected clinical data to determine the phenotypic characteristics of the patient will be obtained from available medical records or. at their regular outpatient reading.

After 12-hour fasting overnight, the patients will undergo 2h hyperglycaemic clamp.

During hyperglycemia a sample of venous blood for the evaluation of oxidative stress, inflammatory response and the expression of non-coding RNA is going to be drawn.

Subjects will have 1H-MRS in hyperglycaemic and euglycaemic state and evaluation of executive function (using psychological tests) is going to be preformed. For 1H-MRS, the MRI of the head in order to obtain anatomical data is going to be preformed at first .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • T1D on insulin pump, no diabetic complication, normal BMI and blood pressure

排除标准

  • 未提供

结局指标

主要结局

prolonged reaction time

时间窗: during the MRI in hyperglycaemia

次要结局

未报告次要终点

研究者

发起方
University of Ljubljana, Faculty of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tadej Battelino

prof. dr. Tadej Battelino, MD

University of Ljubljana, Faculty of Medicine

研究点 (2)

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