Risk Model of Cognitive Impairment in Diabetes

Recruiting

• Conditions: Type 2 Diabetes Mellitus; Mild Cognitive Impairment
• Interventions: Other: Tests

• Registration Number: NCT05590442
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation cohort	Tests	The validation cohort will be used to validate the results obtained using the training cohort.
Training cohort	Tests	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Glycaemic control measured by blood test.	1 day	HbA1c
Physical assessments.	1 day	BMI(body mess index) in kg/m\^2

Trial Locations

Locations (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China