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Risk Model of Cognitive Impairment in Diabetes

Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05590442
Enrollment
500
Registered
2022-10-21
Start date
2022-09-01
Completion date
2025-08-31
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus, Mild Cognitive Impairment

Keywords

Cognitive Assessments, Olfactory Test, Risk Model

Brief summary

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

Interventions

OTHERTests

Cognitive assessments and olfactory tests

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rate of mild cognitive impairment occurrence1 yearThe rate of Montreal Cognitive Assessment(MoCA) scores less than 26 points after 1 year's follow-up.

Secondary

MeasureTime frameDescription
Glycaemic control measured by blood test.1 dayHbA1c
Physical assessments.1 dayBMI(body mess index) in kg/m\^2
Olfactory threshold test1 dayThe 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 test1 dayPART 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) score1 dayThe MoCA is a cognitive screening test designed to assist health professionals in detection of mild cognitive impairment.

Countries

China

Contacts

Primary ContactBi Yan, MD, PhD
biyan@nju.edu.cn+8602583106666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026