Establish Diagnostic Models Based on Olfactory Function and Odor-induced Brain Activation for Diabetes-Related Cognitive Impairment
NCT ID: NCT05543967
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-10-18
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Type 2 Diabetes Mellitus
These patients must have a definite diagnosis of type 2 diabetes mellitus (T2DM) according to the American Diabetes Association (ADA) standards. Some of these patients have symptoms of cognitive impairment, while others have normal cognition. All T2DM patients will undergo physical exam, cognitive and olfactory test as well as structural and brain functional MRI at baseline and follow-up time points.
Cognitive assessments
Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Boston Naming Test (BNT), Digit Span Test (DST), Trail Making Test (TMT).
Olfactory function measurements
Olfactory Threshold, Odor Identification Score, Odor Memory Score.
Functional magnetic resonance imaging
resting-state fMRI, odor-induced fMRI.
Healthy Control
These participants have normal glucose tolerance and normal cognition. All HC subjects will undergo physical exam, cognitive and olfactory test as well as structural and brain functional MRI at baseline and follow-up time points.
Cognitive assessments
Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Boston Naming Test (BNT), Digit Span Test (DST), Trail Making Test (TMT).
Olfactory function measurements
Olfactory Threshold, Odor Identification Score, Odor Memory Score.
Functional magnetic resonance imaging
resting-state fMRI, odor-induced fMRI.
Interventions
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Cognitive assessments
Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Boston Naming Test (BNT), Digit Span Test (DST), Trail Making Test (TMT).
Olfactory function measurements
Olfactory Threshold, Odor Identification Score, Odor Memory Score.
Functional magnetic resonance imaging
resting-state fMRI, odor-induced fMRI.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Right handedness
* Possessed over 6-year education
* Provision of informed consent prior to any study specific procedures
* Disease duration of T2DM patients \>1 year
Exclusion Criteria
* Control participants would be excluded if they had a Montreal Cognitive Assessment (MoCA, Beijing edition) score of \< 26
* Any acute disease
* History of neurologic or psychological illness
* Abnormal results of thyroid hormones, vitamin B12, and folate
* Metal implants, unable to complete the MR scanning
* Partial or complete olfactory dysfunction associated with sinusitis, allergic rhinitis, and deviated nasal septum
* Pregnant or lactating women
* Participating in other clinical trials at the same time or within 6 months prior to the start of the trial
40 Years
75 Years
ALL
Yes
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Locations
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Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-LCYJ-PY-15
Identifier Type: -
Identifier Source: org_study_id
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