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

NCT05262257 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-16

No results posted yet for this study

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.

Conditions

  • Type2 Diabetes

Interventions

DRUG

Metformin

Take it regularly for 12 weeks

DRUG

Dapagliflozin

Take it regularly for 12 weeks

BEHAVIORAL

Lifestyle intervention

patients did not take any hypoglycemic drugs and adopted diet, exercise and other lifestyle intervention measures to control blood sugar.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-12-30
Completion
2023-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262257 on ClinicalTrials.gov