研究疾病:
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糖尿病轻度认知功能障碍
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研究疾病代码:
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Target disease:
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DM-mild CognitiveImpairment
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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非随机对照试验
Non randomized control
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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通过多模式MRI和分析方法,可以多角度、多层次地表达“脑龄”的临床实践,探讨糖尿病引起认知障碍的中枢机制,表达其调控机制
针灸改善认知功能。
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Objectives of Study:
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By using multi-mode MRI and analysis methods, we can express the clinical practice of "brain age" from multiple perspectives and levels, explore the central mechanism of cognitive impairment caused by diabetes, and express the regulatory mechanism of acupuncture to improve cognitive function
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1.2型糖尿病轻度认知功能障碍组:必须符合以下7项全部者方可纳入T2DM-MCI临床研究对象:①符合T2DM诊断标准,年龄45-65岁,男女不限;②符合MCI诊断标准,MCI发生在T2DM确诊后;③整体认知功能完好,即MMSE27-30分;④工具性日常生活能力基本保留,即IADL≤9分/8项;⑤无痴呆;⑥右利手;⑦患者本人及监护人共同签署知情同意书。2.2型糖尿病认知功能正常组:必须符合以下7项全部者方可纳入T2DM-NC临床研究对象:①符合T2DM诊断标准,年龄45-65岁,男女不限;②不伴有其他可能导致认知功能损害的病史;③无记忆或其他认知损害;④不符合MCI诊断标准,亦不符合痴呆诊断标准;⑤整体认知功能完好,即MMSE 27-30分;⑥右利手;⑦患者本人签署知情同意书。入组匹配:T2DM-NC入组患者的年龄、性别、学历需与2型糖尿病轻度认知功能障碍患者进行匹配,糖尿病病程上保持组间目标一致。3.健康对照组:必须符合以下6项全部者方可纳入HC临床研究对象:①不伴有糖尿病病史及其他可能导致认知功能损害的病史;②有不稳定的轻微记忆减退,或无记忆或其他认知损害;③不符合MCI诊断标准,亦不符合痴呆诊断标准;④整体认知功能完好,即MMSE 27-30分;⑤右利手;⑥受试者本人签署知情同意书。符合入组匹配。
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Inclusion criteria
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The inclusion criteria were as follows:1. T2DM-MCI Group: ①meet the diagnostic criteria of T2DM, age 45-65 years, male or female; ②meet the diagnostic criteria of MCI, MCI occurs after the diagnosis of T2DM; ③overall cognitive function is intact, i.e., MMSE score of 27-30; ④instrumental daily living ability is basically preserved, i.e., IADL≤9 points/8 items; ⑤no dementia; ⑥right-hand dominance;⑦the patient and guardian jointly sign the informed consent. 2. T2DM-NC Group: ①meet the diagnostic criteria of T2DM, age 45-65 years old, male or female; ②no other medical history that may lead to cognitive impairment; ③no memory or other cognitive impairment; ④do not meet the diagnostic criteria of MCI or dementia; ⑤overall cognitive function is intact, i.e., MMSE 27-30 score; ⑥right-hand dominance; ⑦the patients themselves signed the informed consent. Enrollment matching: The age, gender and education of patients enrolled in T2DM-NC should be matched with those with mild cognitive impairment in type 2 diabetes, and the target of the group should be consistent in the duration of diabetes. 3. Healthy Control Group: ①no history of diabetes and other medical history that may lead to cognitive impairment; ② unstable mild memory loss or no memory or other cognitive impairment; ③do not meet the diagnostic criteria of MCI or dementia; ④overall cognitive function is intact, i.e., MMSE 27-30 score; ⑤right-handedness; ⑥the participants signed the informed consent. The age, gender and education of participants should be matched between groups.
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排除标准:
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具备以下8项中任何一项者,不可被纳入临床研究对象:①已知认知损害为可逆性原因造成者,如VitB12或叶酸缺乏或甲状腺功能减退;②认知损害由其他不可逆原因造成,如脑血管疾病、颅脑肿瘤、头部外伤、中毒等;③严重焦虑或抑郁状态(HAMD17项>24分,HAMA>29分),或存在其他精神障碍;④严重的药物或酒精滥用史;⑤一个月内服用影响认知的副作用的药物;⑥在评价48小时内服用过拟交感药物、抗组胺药物、抗焦虑、安定类药物;在评价前72小时内服用过抗精神病类药物;⑦不能配合完成认知功能测评;⑧体内有金属,或存在其他核磁检查禁忌症。
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Exclusion criteria:
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The exclusion criteria were as follows:①cognitive impairment is known to be caused by reversible causes, such as VitB12 or folic acid deficiency or hypothyroidism; ②cognitive damage is caused by other irreversible causes, such as cerebrovascular disease, craniocerebral tumor, head trauma, poisoning, etc.; ③severe anxiety or depression (HAMD 17 items>24 points, HAMA>29 points), or other mental disorders; ④any severe history of alcohol abuse or drug dependency; ⑤have taken medications with side effects that affect cognition within a month⑥have taken sympathomimetic drugs, antihistamines, anti-anxiety drugs, and tranquilizers within 48 hours; have taken antipsychotic drugs within 72 hours before the evaluation;⑦unable to cooperate in completing the cognitive function assessment⑧there are metals in the body, or any other MRI contraindications.
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研究实施时间:
Study execute time:
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从From
2022-01-01
至To
2024-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-08-23
至To
2024-12-31
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