type 2 diabetes mellitus with cognitive impairment
Conditions
Interventions
Control group (routine care group):The control group received standard drug treatment and dietary recommendations provided by physicians following the "China Type 2 Diabetes Prevention and Treatment G
Experimental group (CMNT group):Participants in the CMNT group will eat the provided CMNT diet for 5 consecutive days in each intervention cycle, eating breakfast, lunch and dinner at the usual time b
Sponsors
University of South China
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients have been diagnosed with T2DM for a duration of = 2 years; BMI between 18.0 and 35.0 kg/m2; Weight stable for at least 3 months prior to the study (gain or loss < 4 kg); Aged 60–75 years with more than 6 years of education no language communication barriers visual impairments or auditory impairments and able to complete cognitive assessments and neuropsychological tests; Montreal Cognitive Assessment (MoCA) score of <26 (with an adjustment of +1 point for participants with <12 years of education to account for cultural effects). No significant impairment in activities of daily living with a score of =16 on the Instrumental Activities of Daily Living (IADL) scale; No evidence of infection infarction or other focal brain lesions on cranial CT or MRI scans conducted within the 12 months prior to screening and no relevant clinical symptoms. Non-critical white matter changes or lacunar infarcts in non-essential brain regions are permitted provided they do not affect cognitive function. Able to provide written informed consent; Able to successfully complete a 2–3-week trial period.
Exclusion criteria
Exclusion criteria: Having diabetes other than Type 2 diabetes mellitus (T2DM); Allergic to CMNT ingredients; Scheduled or anticipated hospitalization during the trial; Unable to comply with the procedures required by the study protocol due to physical or mental reasons; Having experienced at least three Grade 3 hypoglycemic events within 90 days prior to screening. Hospitalization or emergency department visits due to hyperglycemia diabetic ketoacidosis lactic acidosis hyperosmolar non-ketotic coma or diabetes; Having severe systemic diseases that may affect cognitive function (such as cardiovascular pulmonary hepatic renal or hematologic diseases); History of cerebrovascular diseases such as cerebral infarction cerebral hemorrhage central nervous system infection brain tumor or other focal brain damage; Neurological diseases that can cause dementia such as Alzheimer's disease or Parkinson's disease; history of severe traumatic brain injury resulting in persistent neurological deficits or structural brain abnormalities; History of depression within the past 2 years; History of alcohol tobacco or drug abuse or dependence within the past 2 years; Use of the following classes of medications within 30 days prior to cognitive impairment screening: medications for the treatment of Alzheimer's disease or dementia anti-Parkinson's disease drugs short-acting anxiolytics neuroleptic or analgesic drugs antiepileptic drugs hormones or drugs with significant cholinergic or anticholinergic side effects; History of cancer within the past 5 years; Having New York Heart Association Class III or IV decompensated heart failure; History of unstable angina coronary artery bypass grafting myocardial infarction or stent implantation; Having metal implants in the body; having claustrophobia; Any other condition that the investigator or the medical expert of this study deems unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function score;Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRP,IL-6;Digit Symbol Substitution Test,DSST;Hypoglycemic drug dosage;Anthropometric ;Self-Rating Anxiety ScaleSAS;Intestinal flora metabolites;Glucose metabolism;Instrumental Activities of Daily Living Scale;Self-rating Depression Scale;Fried asthenic syndrome criteria;Intestinal microbiome analysis;MRI;Blood lipid; | — |
Countries
China
Contacts
Public ContactHe Hailong
University of South China; The First Affiliated Hospital of University of South China
Outcome results
None listed