Risk Model of Cognitive Impairment in Diabetes

Nanjing University

Status: Enrolling

Conditions: Mild Cognitive Impairment; Type 2 Diabetes Mellitus

Treatments: Other: Tests

Study type: Observational

Funder types: Other

Identifiers

NCT05590442

MCImodel2022

Details and patient eligibility

About

Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.

Enrollment: 500 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes mellitus ;
• Aged:40 -80 years ;
• Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30;

Exclusion criteria

• Mini-mental State Examination(MMSE) scores < 24;
• Other dementia related neurological diseases or depression, schizophrenia in the past 2 years;
• Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction;
• Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions, congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction;
• Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or severe hypoglycemic coma.

Trial design

500 participants in 2 patient groups

Training cohort

Description:

The patients will be divided into the training and validation cohorts with a ratio of 7:3. The training cohort will be used to screen variables and construct the model.

Treatment:

Other: Tests

Validation cohort

Description:

The validation cohort will be used to validate the results obtained using the training cohort.

Treatment:

Other: Tests