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Clinical Trial Details

Trial ID: L3141
Source ID: NCT05262257
Associated Drug: Metformin
Title: Evaluation and Intervention of Cognitive Function in Patients With Diabetes Mellitus.
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2 Diabetes
Interventions: DRUG: Metformin|DRUG: Dapagliflozin|BEHAVIORAL: Lifestyle intervention
Outcome Measures: Primary: Event-related potential (ERP), Event-related potential (ERP) is a potential change in a region of the brain caused by the addition of a specific stimulus to a specific part of the sensory system or brain when the stimulus is given or withdrawn. It is suitable for the assessment of cerebral dysfunction, especially for the population with early subclinical disease. Among them, P300 belongs to a kind of ERP, which is an endogenous special evoked potential related to cognitive function, and can recognize and evaluate the early changes of cognitive function, it can provide reliable and objective indexes for the change of cognitive function in clinical nerve or mental disease, and is of great significance for early drug intervention and improvement of patients'long-term quality of life. The measurements of P300 include the determination of the latency and amplitude of N2, P3a and P3b., 12 weeks|Montreal Cognitive Assessment(MoCA), The Montreal Cognitive Assessment(MoCA) is a rapid screening tool for mild cognitive impairment (MCI) developed by Professor Nasreddine in 2004, the cognitive areas assessed included attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation and orientation. The total score of the scale was 30. The test result showed that the normal score was ≥26., 12 weeks|Mini-Mental State Examination(MMSE), Mini-Mental State Examination(MMSE) includes the following seven aspects: time orientation, place orientation, immediate memory, attention and calculation, delayed memory, language, visual space. A total of 30 questions, the correct answer to each score of 1, wrong answer or do not know the score of 0, the total score of the scale ranges from 0 to 30. The test scores are closely related to the educational level, and the normal cut-off points are as follows: illiteracy\>17 points, primary school\>20 points, junior middle school and above\>24 points., 12 weeks | Secondary: glycated hemoglobin(HbA1c、GHb), The concentration of glycosylated hemoglobin can effectively reflect the average blood glucose level in the past 8-12 weeks. After 12 weeks of intervention, the changes of glycosylated hemoglobin in patients with type 2 diabetes reflect the therapeutic effect, and the intervention measures are adjusted according to glycosylated hemoglobin., 12 weeks
Sponsor/Collaborators: Sponsor: The First Affiliated Hospital with Nanjing Medical University
Gender: ALL
Age: ADULT
Phases: EARLY_PHASE1
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2022-04-01
Completion Date: 2023-12-30
Results First Posted:
Last Update Posted: 2022-03-16
Locations:
URL: https://clinicaltrials.gov/show/NCT05262257