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This study is a randomized controlled, single-center study of the cognitive function of diabetic patients in the Department of Endocrinology in our hospital. Through the collection of clinical data during the outpatient or hospitalization period, as well as the clinical data of follow-up at different times in the later period, the conclusion is drawn after statistical analysis. For the population who passed the observational study in the first part, patients who meet the conditions of intervention will be further screened to enter the intervention study in the second part. Patients with type 2 diabetes who meet the enrollment criteria and enter the second part are randomly divided into 3 groups according to 1:1:1; 1.Lifestyle intervention group; 2. Metformin treatment group; 3. Dapagliflozin treatment group; There are four groups with healthy control (no intervention). Follow-up review and blood samples were taken after 12 weeks respectively. After the first follow-up, follow-up can be extended to 24 weeks depending on the patient's wishes. Combined with the number of patients with diabetes in endocrinology department of our hospital in the past, and considering the nature of this study and other factors, 90 patients with type 2 diabetes and 30 healthy controls were included for research and analysis.
A large amount of evidence indicates that diabetes (DM) is related to mild cognitive impairment (MCI), vascular dementia and Alzheimer disease (AD). Biological, clinical and epidemiological data all support the close link between diabetes and Alzheimer disease. AD and type 2 diabetes (T2DM) have common pathological features, including inflammation, changes in insulin signaling, or vascular damage. Event-related potential (ERP) is a specific stimulus that acts on the sensory system or a certain part of the brain. When the stimulation is given or withdrawn, the potential change in the brain area is caused. It is suitable for the assessment of brain dysfunction, especially for the assessment of people with early subclinical disease states. Among them, P300 belongs to a kind of ERP, which is an endogenous special evoked potential related to cognitive function. It can identify and evaluate early changes in cognitive function. Therefore, it can be recognized in clinical neurological or psychiatric diseases. The change of cognitive function provides reliable objective indicators, which is of great significance for early drug intervention and treatment and improving the long-term quality of life of patients. Studies have found that anti-diabetic drugs can improve cognitive and memory impairment, and have a positive effect on mitochondrial and synaptic function, neuroinflammation and brain metabolism. Anti-diabetic drugs can be developed as the treatment of MCI and AD diseases in diabetic and non-diabetic patients. Both basic and clinical trials have evidence that metformin has considerable potential for the treatment of cognitive dysfunction in T2DM. Basic experiments have confirmed that SGLT-2 inhibitors may improve the pathological state of AD, but the clinical evidence is still unclear. As the representative drug of SGLT-2, dapagliflozin, as the intervention drug in this study, focuses on its effect on improving the cognitive function of diabetic patients, and compares its effectiveness in improving cognitive function with metformin.
This study is a randomized controlled, single-center study of the cognitive function of diabetic patients in the Department of Endocrinology in our hospital. Through the collection of clinical data during the outpatient or hospitalization period, as well as the clinical data of follow-up at different times in the later period, the conclusion is drawn after statistical analysis. For the population who passed the observational study in the first part, patients who meet the conditions of intervention will be further screened to enter the intervention study in the second part. Patients with type 2 diabetes who meet the enrollment criteria and enter the second part are randomly divided into 3 groups according to 1:1:1;1.Lifestyle intervention group; 2. Metformin treatment group; 3. Dapagliflozin treatment group; There are four groups with healthy control (no intervention). Follow-up review and blood samples were taken after 12 weeks respectively. After the first follow-up, follow-up can be extended to 24 weeks depending on the patient's wishes. Combined with the number of patients with diabetes in endocrinology department of our hospital in the past, and considering the nature of this study and other factors, 90 patients with type 2 diabetes and 30 healthy controls were included for research and analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention group | Experimental | patients did not take any hypoglycemic drugs and adopted diet, exercise and other lifestyle intervention measures to control blood sugar. |
|
| Metformin treatment group | Experimental | on the basis of lifestyle intervention, patients were given metformin 2-3 times a day (starting with 2times), 0.5g each time. |
|
| Dapagliflozin treatment group | Experimental | on the basis of lifestyle intervention, patients took Dapagliflozin orally, once a day, 10mg at a time. |
|
| Healthy control group | No Intervention | no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Take it regularly for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
some patients with type 2 diabetes were observed and studied:
healthy controls were age, sex and weight matching:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29626315 | Background | Zhong KL, Chen F, Hong H, Ke X, Lv YG, Tang SS, Zhu YB. New views and possibilities of antidiabetic drugs in treating and/or preventing mild cognitive impairment and Alzheimer's Disease. Metab Brain Dis. 2018 Aug;33(4):1009-1018. doi: 10.1007/s11011-018-0227-1. Epub 2018 Apr 6. | |
| 31430566 | Background | Xue M, Xu W, Ou YN, Cao XP, Tan MS, Tan L, Yu JT. Diabetes mellitus and risks of cognitive impairment and dementia: A systematic review and meta-analysis of 144 prospective studies. Ageing Res Rev. 2019 Nov;55:100944. doi: 10.1016/j.arr.2019.100944. Epub 2019 Aug 17. |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Dapagliflozin | Drug | Take it regularly for 12 weeks |
|
|
| Lifestyle intervention | Behavioral | patients did not take any hypoglycemic drugs and adopted diet, exercise and other lifestyle intervention measures to control blood sugar. |
|
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