Risk Model of Cognitive Impairment in Diabetes

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)

Overall Status

Recruiting

CT.gov ID

NCT05590442

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Mild Cognitive Impairment	Other: Tests

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Training cohort 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.	Other: Tests Cognitive assessments and olfactory tests
Validation cohort The validation cohort will be used to validate the results obtained using the training cohort.	Other: Tests Cognitive assessments and olfactory tests

Arm

Intervention/Treatment

Training cohort

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.

Other: Tests

Cognitive assessments and olfactory tests

Validation cohort

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

Other: Tests

Cognitive assessments and olfactory tests

Outcome Measures

Primary Outcome Measures

The rate of mild cognitive impairment occurrence [1 year]
The rate of Montreal Cognitive Assessment(MoCA) scores less than 26 points after 1 year's follow-up.

Secondary Outcome Measures

Glycaemic control measured by blood test. [1 day]
HbA1c
Physical assessments. [1 day]
BMI(body mess index) in kg/m^2
Olfactory threshold test [1 day]
The same odor with 2 different concentrations are given to the participant each time to find out which one is more intense. (Olfactory software will analyse and give threshold score depending on participant's choice.)
Olfactory memory test [1 day]
PART A: Participants are shown 4 pictures for each odor(10 odors in total). They select what they sniffed. 10 minutes break. PART B: Participants sniff 20 different odors , 10 of which are same odors in PART A. They select the picture and figure out whether the odor is old or new.
Montreal Cognitive Assessment (MoCA) score [1 day]
The MoCA is a cognitive screening test designed to assist health professionals in detection of mild cognitive impairment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.