Study on Multi-modal Brain Imaging Effects and Endoplasmic Reticulum Stress Mechanism of Electroacupuncture of Adjust ''Zang-fu and Arouse Spirit'' on Diabetic Cognitive Dysfunctio
- Conditions
- Diabetic cognitive impairment (DCI)
- Registration Number
- ITMCTR2000004084
- Lead Sponsor
- Changchun University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Inclusion Criteria for Subjects with Diabetic Cognitive Impairment
(1) The 2020 American Diabetes Association (ADA) Standards of Medical Practice for diabetes with a duration >=2 years;
(2) Signs or symptoms of memory loss;
(3) Montreal Cognitive Assessment Scale (MoCA) score <26, Clinical Dementia Rating (CDR)>=0.5;
(4) Activities of daily living (ADLs) were not significantly affected,instrumental ability of daily living (IADL) score>=16;
(5) Aged 50-70 years, with more than 6 years of education, able to complete a cognitive assessment;
(6) Sufficient visual and auditory discrimination to undergo neuropsychological testing;
(7) No evidence of infection, infarction, or other focal injury, or associated clinical symptoms, as detected by transcranial CT or MRI in the 12 months prior to screening; allows for white matter lesions or cavitary infarcts in non-critical brain regions without affecting the subject's cognitive function;
(8) Signed informed consent, volunteered to participate in the study, and were able to cooperate with the physician in completing the clinical study;
2. Inclusion Criteria for Healthy Subjects
(1) Conditions such as age, education, etc. are comparable to other groups of subjects;
(2) The absence of significant neurological foci and the absence of associated disorders that could cause cognitive impairment, as determined by cranial MRI;
(3) No religious beliefs, no tobacco, alcohol, coffee, tea or other bad habits;
(4) No job or life stress during the observation period;
(5) Be in good health, free of cardiovascular and other organic diseases;
(6) Total MoCA score>=26;
(7) Signed informed consent, volunteered to participate in the study, and were able to cooperate with the physician in completing the clinical study.
(1) Sensitive to acupuncture;
(2) Subjects with significant auditory, visual, or speech impairments affecting cognitive function testing;
(3) Acute complications of diabetes such as diabetic ketoacidosis and hypertonic coma within the last 3 months; significant cardiopulmonary, hepatic, renal, and hematologic diseases that may affect cognitive function;
(4) A history of previous cerebrovascular disease such as cerebral infarction, cerebral hemorrhage, or other focal injury that affects cognition; vascular dementia (Hachinski Ischemia Index score >=7) and neurological disorders that can cause dementia such as Alzheimer's disease and Parkinson's disease; a history of severe traumatic brain injury with persistent neurological deficits or known structural brain abnormalities;
(5) Depression within the past 2 years with an Anxiety Self-Assessment Scale (SAS) or Depression Self-Assessment Scale (SDS) score >50;
(6) History of alcohol, tobacco, drug abuse, or dependence within the past 2 years;
(7) Use of medications in the following categories within 30 days prior to screening for cognitive impairment: medications for Alzheimer's disease or dementia, antiparkinsonian medications, short-acting anxiolytics, neuroleptic or analgesic medications, antiepileptic medications, hormones, medications with significant cholinergic or anticholinergic side effects;
(8) More pronounced cerebral white matter lesions or cavitary infarction (subject's age-related white matter change (ARWMC) score >=2);
(9) Patients with implanted metals, such as pacemakers, defibrillators, cardiac stents, artificial heart valves, metal clips after aneurysm surgery, drug perfusion devices, nerve stimulators, bone growth stimulators and any other types of biological stimulators, metal suture, etc. Patients with bullets, broken shrapnel or screws in the body, or patients with fixed plates, screws and screws in the body after fracture; Patients with artificial limbs or joints, penile prostheses, hearing AIDS, cochlear implants, middle ear implants, metal foreign bodies in the eyes, artificial eyes and implants in the head and face, etc.;
(10) Patients with claustrophobia.
Study & Design
- Study Type
- Basic Science
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method functional Magenetic Resonance Imaging;Montreal Cognitive Assessment (MoCA);Clinical Dementia Rating(CDR);
- Secondary Outcome Measures
Name Time Method Triglyceride;High-density Lipoprotein;Hachinski Ischemic Scale(HIS);Instrumental activities of daily living scale(IADL);Total Cholesterol;Low-density Lipoprotein;HemoglobinA1c(HbA1c);Self-rating depression scale(SDS);Self-Rating Anxiety Scale(SAS);