Study on the expression profiles of miRNAs-LncRNA in type 2 diabetes-mellitus-mild cognitive impairment with deficiency-excess syndrome of traditional Chinese medicine

Phase 1

• Conditions: type 2 diabetes-mellitus-mild cognitive impairment

• Registration Number: ITMCTR2000003443
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Aged 45 to 75 years; gender is not limited; the diagnosis of Diabetes Mellitus meets the criteria established by WH0 in 1999, and the subject is clearly diagnosed as type 2 Diabetes Mellitus.
(2) The main complaint of memory impairment is confirmed by others.
(3) Clinical evaluation confirmed the existence of cognitive impairment, MOCA <26 points (using the Beijing version, the full score of the scale is 30 points, if the education period is <= 12 years, then add 1 point to the test results to correct the bias).
(4) The clinical dementia rating (CDR) is 0.5 points, and the memory item of the amnestic CDR scale scored at least 0.5 points.
(5) The total cognitive function is fully preserved, the scores of mini-mental state examination(MMSE) were graded according to education background, the illiterate group > 18 points, the primary school group > 21 points, the junior high school or above group > 24 points indicated that the cognitive function is preserved.
(6) Activities of daily living are in good condition or have very minor damage, such as instrumental activities of daily living (IADL) score is greater than or equal to 16 points.
(7) Have sufficient visual and auditory resolution to undergo neuropsychological testing.
(8) There is no evidence of infection, infarction or other focal injury in the CT or MRI scan within 12 months prior to MCI screening, and there is no related clinical symptoms, but lacunar infarction in a non-critical brain region is allowed and it is not considered to affect the cognitive impairment of the subjects; the Hachinski Ischemia Scale (HIS) score is less than or equal to 4 points. Subjects voluntarily joined the study and signed informed consent.

Exclusion Criteria

(1) Acute complications such as diabetic ketoacidosis in the past 3 months;
(2) History of severe heart, lung and kidney failure;
(3) suffering from depression within the past 2 years, the General Hospital Anxiety/Depression Sex Measurement Form (SDS) score >= 50 points.
(4) History of alcohol, drug abuse or dependence within the past 2 years.
(5) The following drugs have been used within 1 month before cognitive impairment screening: anti-Parkinson's disease drugs, short acting anti-anxiety agents, sedative drugs, anti-pain drugs, drugs with obvious cholinergic or anti cholinergic adverse reactions.
(6) Patients have no complete datas.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mini-mental state examination scale;Instrumental activities of daily living scale;Depression self-rating scale;FINS;F-CP;Patients miRNA;TCM syndrome type questionnaire;Anxiety self-rating scale;HBA1C;Hachinski ischemic index scale;Montreal Cognitive Assessment Scale;FBG;PBG;Clinical dementia grading scale;