Cognitive Impairment in Type 2 Diabetes Mellitus
Conditions
Interventions
The research group:The acupuncture and healthy instruction
The placebo group:The placebo acupuncture and healthy instruction
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for subjects with Type 2 diabetes mellitus with mild cognitive impairment (T2DM-MCI): (1) Diagnosed with Type 2 diabetes mellitus (T2DM) duration of illness =2 years with stable and well-controlled blood glucose levels; right-handed; (2) Presence of subjective complaints or objective evidence of memory decline; (3) Montreal Cognitive Assessment (MoCA) score =18 and <26; (4) Activities of daily living are not significantly impaired (Instrumental Activities of Daily Living \[IADL] =16); (5) Aged 40–70 years with =6 years of formal education and able to complete cognitive assessments; (6) Sufficient visual auditory and language abilities to complete neuropsychological tests; (7) Signed informed consent form voluntarily and able to cooperate with researchers to complete clinical research. Inclusion criteria for healthy control subjects: (1) Age education level and other demographic characteristics matched with participants from other groups; (2) No obvious neurological lesions confirmed by cranial MRI and no diseases known to impair cognitive functions; (3) No diabetes with normal blood glucose levels; (4) No religious beliefs; no habits of smoking alcohol consumption coffee or tea intake or other adverse habits; (5) Generally healthy with no significant cardiovascular pulmonary hepatic renal or hematological diseases; (6) Montreal Cognitive Assessment (MoCA) total score =26; (7) Signed informed consent form voluntarily and able to cooperate with researchers to complete clinical research.
Exclusion criteria
Exclusion criteria: Exclusion criteria for subjects with type 2 diabetes mellitus with mild cognitive impairment (T2DM-MCI): (1) History of needle fainting or sensitivity to acupuncture; skin lesions infections or lumps at the intended needle insertion sites; (2) Acute diabetic complications such as diabetic ketoacidosis or hyperosmolar coma within the past 3 months; (3) Severe cardiovascular pulmonary hepatic renal or hematological diseases that may affect cognitive function; (4) Endocrine disorders or medications affecting blood glucose levels such as hyperthyroidism Cushings syndrome or glucocorticoid treatment; (5) History of cerebrovascular diseases (e.g. cerebral infarction or hemorrhage) central nervous system infections brain tumors or other focal brain lesions affecting cognition; vascular dementia (Hachinski ischemic score =7) Alzheimers disease Parkinsons disease or other neurological diseases causing dementia; severe traumatic brain injury with residual neurological deficits or known structural brain abnormalities; (6) History of depression within the past 2 years Self-rating Anxiety Scale (SAS) or Self-rating Depression Scale (SDS) scores >50; history of other psychiatric disorders or family history of psychiatric illnesses; (7) History of alcohol abuse smoking or drug abuse or dependence within the past 2 years; (8) Use of the following categories of medications within 30 days before cognitive screening: Alzheimers disease or dementia medications anti-Parkinson drugs short-acting anxiolytics neuroleptics or analgesics antiepileptic drugs hormones or drugs with significant cholinergic or anticholinergic side effects; (9) Presence of significant cerebral white matter lesions or lacunar infarctions (Age-Related White Matter Changes \[ARWMC] score =2); (10) Implanted metal objects such as cardiac pacemakers defibrillators cardiac stents artificial heart valves aneurysm clips drug infusion devices nerve stimulators bone growth stimulators or any type of bio-stimulator; metallic surgical sutures bullets shrapnel or pellets or internal fixation devices after fractures (plates screws nails); artificial limbs or joints penile implants hearing aids cochlear implants middle ear prostheses intraocular metallic foreign bodies prosthetic eyes or facial implants; (11) Claustrophobia; (12) Coagulation disorders; (13) Pregnant or lactating women. Exclusion criteria for healthy control subjects: (1) History of depression within the past 2 years Self-rating Anxiety Scale (SAS) or Self-rating Depression Scale (SDS) scores >50; history of other psychiatric disorders or family history of psychiatric illnesses; (2) Use of the following categories of medications within 30 days before screening: Alzheimers disease or dementia medications anti-Parkinson drugs short-acting anxiolytics neuroleptics or analgesics antiepileptic drugs hormones or drugs with significant cholinergic or anticholinergic side effects; (3) Implanted metal objects such as cardiac pacemakers defibrillators cardiac stents artificial heart valves aneurysm clips drug infusion devices nerve stimulators bone growth stimulators or any type of bio-stimulator; metallic surgical sutures bullets shrapnel or pellets or internal fixation devices after fractures (plates screws nails); artificial limbs or joints penile implants hearing aids cochlear implants middle ear prostheses intraocular metallic foreign bodies prosthetic eyes or facial implants; (4) Claustrophobia; (5) Pregnant or lactat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ontreal Cognitive Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| NF-?B;;;CDT;BDNF;;inflammatory factor;Stroop Test;;; | — |
Countries
China
Contacts
Public ContactShijun Qiu
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed