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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05262257
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
40 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin — DRUG
    Take it regularly for 12 weeks
  • 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2022
Status verified
Mar 2022
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lifestyle intervention group
    patients did not take any hypoglycemic drugs and adopted diet, exercise and other lifestyle intervention measures to control blood sugar.
  • Experimental: Metformin treatment group
    on the basis of lifestyle intervention, patients were given metformin 2-3 times a day (starting with 2times), 0.5g each time.
  • Experimental: Dapagliflozin treatment group
    on the basis of lifestyle intervention, patients took Dapagliflozin orally, once a day, 10mg at a time.
  • No Intervention: Healthy control group
    no intervention.

Primary Outcome Measure

Event-related potential (ERP) [ Time Frame: 12 weeks ]

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