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临床试验/NCT05919927
NCT05919927进行中(未招募)不适用

Effects of Type II Diabetes on Cognitive Functions in Middle-aged Patients

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Sum score of the Z-scores of the performed standardized neuropsychological tests

研究概览

简要总结

This study will examine the effects of type II diabetes on cognitive functions and mood in middle-aged patients. In addition, the association between cognitive functions and glycemic controls is studied in patients. Sixty patients and sixty healthy controls will be recruited and assessed by a multiprofessional team (neuropsychologist, physician).

详细描述

Sixty patients with type 2 diabetes will be recruited from the Tampere Diabetes outpatient clinic. Inclusion criteria for the patients are type 2 diabetes diagnosis, diabetes medication and age 35-65. Exclusion criteria are type 1 diabetes, hypothyreosis, neurological or psychiatric disorder, substance abuse and serious diabetes complications. Sixty healthy control persons are recruited from the personnel and occupational health care. Exclusion criteria for controls are type 1 or 2 diabetes, hypothyreosis, neurological or psychiatric disease and substance abuse.

A comprehensive neuropsychological assessment is made to all participants.The assessment consists of standardized neuropsychological tests, questionnaires and interview. Domains assessed include attention, executive functions, memory, information processing speed, general cognitive functioning, depressive symptoms, anxiety and fatigue. Medical information (such as glycated hemoglobin and blood pressure) from the patients is gathered from the medical records. Corresponding information from the control participants is gathered with medical examinations including laboratory tests. Informed consent is taken from all participants.

This study will examine the difference in cognitive functions between healthy controls and middle-aged patients with type 2 diabetes. There is evidence from previous studies that type 2 diabetes is related to an increased risk of dementia, but the association between diabetes and cognition at younger ages is less studies. The difference in mood and fatigue is also studied between the groups. In addition, the association between glycated hemoglobin level and cognitive functions is examined in patients, as poor glycemic control has been implicated to impact on cognitive decline in previous studies. Finally, the association between history of hypoglycemic episodes and cognition is studied.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type II diabetes, age between 35-65 years

排除标准

  • hypothyreosis, previous neurological diseases

结局指标

主要结局

Sum score of the Z-scores of the performed standardized neuropsychological tests

时间窗: 1 day.

Sum score of the Z-scores of the performed standardized neuropsychological tests (Wechsler Adult Intelligence Scale, Continuous Performance test and Rey-Osterrieth Complex Figure test). Average performances evaluated by the differences in these sum scores are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

Wechsler Adult Intelligence Scale-test

时间窗: 1 day.

Wechsler Adult Intelligence Scale-test and its z-score. Average performance differences in this cognitive test are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

Rey-Osterrieth Complex Figure test

时间窗: 1 day.

Rey-Osterrieth Complex Figure test and its z-score. Average performance differences in this cognitive test are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

Continuous Performance test

时间窗: 1 day.

Continuous Performance test and its z-score. Average performance differences in this cognitive test are compared between healthy controls and patients with type 2 diabetes using SPSS-program.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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