Evaluation and Intervention of Cognitive Function in Patients With Diabetes Mellitus.

Summary

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.

Timeline

Start

2022-04-01

Primary completion

2023-12-30

Completion

2023-12-30

Publications

• 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.
• 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.
• Background Zheng F, Yan L, Yang Z, Zhong B, Xie W. HbA1c, diabetes and cognitive decline: the English Longitudinal Study of Ageing. Diabetologia. 2018 Apr;61(4):839-848. doi: 10.1007/s00125-017-4541-7. Epub 2018 Jan 25.
• Background Baglietto-Vargas D, Shi J, Yaeger DM, Ager R, LaFerla FM. Diabetes and Alzheimer's disease crosstalk. Neurosci Biobehav Rev. 2016 May;64:272-87. doi: 10.1016/j.neubiorev.2016.03.005. Epub 2016 Mar 9.
• Background Cooper C, Sommerlad A, Lyketsos CG, Livingston G. Modifiable predictors of dementia in mild cognitive impairment: a systematic review and meta-analysis. Am J Psychiatry. 2015 Apr;172(4):323-34. doi: 10.1176/appi.ajp.2014.14070878. Epub 2015 Feb 20.
• Background Patrone C, Eriksson O, Lindholm D. Diabetes drugs and neurological disorders: new views and therapeutic possibilities. Lancet Diabetes Endocrinol. 2014 Mar;2(3):256-62. doi: 10.1016/S2213-8587(13)70125-6. Epub 2013 Nov 22.
• Background Paitel ER, Samii MR, Nielson KA. A systematic review of cognitive event-related potentials in mild cognitive impairment and Alzheimer's disease. Behav Brain Res. 2021 Jan 1;396:112904. doi: 10.1016/j.bbr.2020.112904. Epub 2020 Sep 15.
• Background Alvarenga Kde F, Duarte JL, Silva DP, Agostinho-Pesse RS, Negrato CA, Costa OA. Cognitive P300 potential in subjects with Diabetes Mellitus. Braz J Otorhinolaryngol. 2005 Mar-Apr;71(2):202-7. doi: 10.1016/s1808-8694(15)31311-2. Epub 2005 Aug 2.
• Background Lin B, Koibuchi N, Hasegawa Y, Sueta D, Toyama K, Uekawa K, Ma M, Nakagawa T, Kusaka H, Kim-Mitsuyama S. Glycemic control with empagliflozin, a novel selective SGLT2 inhibitor, ameliorates cardiovascular injury and cognitive dysfunction in obese and type 2 diabetic mice. Cardiovasc Diabetol. 2014 Oct 26;13:148. doi: 10.1186/s12933-014-0148-1.
• Background Nguyen T, Wen S, Gong M, Yuan X, Xu D, Wang C, Jin J, Zhou L. Dapagliflozin Activates Neurons in the Central Nervous System and Regulates Cardiovascular Activity by Inhibiting SGLT-2 in Mice. Diabetes Metab Syndr Obes. 2020 Aug 5;13:2781-2799. doi: 10.2147/DMSO.S258593. eCollection 2020.
• Background Wen S, Nguyen T, Gong M, Yuan X, Wang C, Jin J, Zhou L. An Overview of Similarities and Differences in Metabolic Actions and Effects of Central Nervous System Between Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RAs) and Sodium Glucose Co-Transporter-2 Inhibitors (SGLT-2is). Diabetes Metab Syndr Obes. 2021 Jun 29;14:2955-2972. doi: 10.2147/DMSO.S312527. eCollection 2021.
• Background Wicinski M, Wodkiewicz E, Gorski K, Walczak M, Malinowski B. Perspective of SGLT2 Inhibition in Treatment of Conditions Connected to Neuronal Loss: Focus on Alzheimer's Disease and Ischemia-Related Brain Injury. Pharmaceuticals (Basel). 2020 Nov 11;13(11):379. doi: 10.3390/ph13110379.
• Background Hayden MR, Grant DG, Aroor AR, DeMarco VG. Empagliflozin Ameliorates Type 2 Diabetes-Induced Ultrastructural Remodeling of the Neurovascular Unit and Neuroglia in the Female db/db Mouse. Brain Sci. 2019 Mar 7;9(3):57. doi: 10.3390/brainsci9030057.
• Background Fink HA, Jutkowitz E, McCarten JR, Hemmy LS, Butler M, Davila H, Ratner E, Calvert C, Barclay TR, Brasure M, Nelson VA, Kane RL. Pharmacologic Interventions to Prevent Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):39-51. doi: 10.7326/M17-1529. Epub 2017 Dec 19.
• Background Xu X, Sun Y, Cen X, Shan B, Zhao Q, Xie T, Wang Z, Hou T, Xue Y, Zhang M, Peng D, Sun Q, Yi C, Najafov A, Xia H. Metformin activates chaperone-mediated autophagy and improves disease pathologies in an Alzheimer disease mouse model. Protein Cell. 2021 Oct;12(10):769-787. doi: 10.1007/s13238-021-00858-3. Epub 2021 Jul 21.
• Background Khattar D, Khaliq F, Vaney N, Madhu SV. Is Metformin-Induced Vitamin B12 Deficiency Responsible for Cognitive Decline in Type 2 Diabetes? Indian J Psychol Med. 2016 Jul-Aug;38(4):285-90. doi: 10.4103/0253-7176.185952.

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