Evaluation and Intervention of Cognitive Function in Patients With Diabetes Mellitus.
Status:
Not yet recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University