Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Cross-sectional and Longitudinal Study to Establish Diagnostic Models Based on Olfactory Function and Odor-induced Brain Activation for Diabetes-Related Cognitive Impairment
This is a cross-sectional and longitudinal study to establish diagnostic models based on olfactory function assessments and odor-induced brain activation for cognitive impairment in patients with type 2 diabetes mellitus.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Aged 40-75 years - 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 fasting blood glucose level >7.0 mmol/L; glucose level> 7.8 mmol/L after oral glucose tolerance test (OGTT); HbA1c>5.7% - 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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline cognitive performance | The Montreal Cognitive Assessment (MoCA) score, ranges from 0 to 30, and higher scores mean better cognition. | Day 1 of entry study | |
Primary | Baseline olfactory threshold | Olfactory threshold test: score range 1-13.5, which is determined based on a series of binary dilutions of the N-butanol solution in light mineral oil. The higher the score is, the more sensitive the participant is in detecting an odor. Scores of 8-10 were considered normal olfactory sensitivity, whereas scores of 1-3 signified olfactory dysfunction or anosmia, and scores of =10 indicate better olfactory sensitivity. | Day 1 of entry study | |
Primary | Baseline olfactory memory | Olfactory memory test: Part A: Participants are shown 4 pictures for each odor (10 odors in total), then they need to select what they sniffed. Have a 10-minute break. Part B: Participants sniff 20 different odors, 10 of which are the same odors as in Part A. They need to select the picture and figure out whether the odor is old or new. | Day 1 of entry study | |
Primary | Baseline odor-induced brain fMRI activation | Each participant underwent a series of task fMRI scans to measure temporal brain response to four increasing concentrations of lavender odors (0.032%, 0.10%, 0.32%, and 1.0) diluted in 1,2-propanediol (Sigma-Aldrich, St. Louis, MO). The visual cues of "+" and "smell" were used for baseline and odor stimulation, respectively. Each concentration was assessed three times, with fresh air and scent occurring alternately. Participants were instructed to press a button once they smelled the lavender scent. A general linear model was used to estimate odor-induced brain activation. Contrasts between "fresh air > rest" and "scent > rest" for each participant were made to get odor-induced brain activation value. Bilateral parahippocampus, amygdala, piriform cortex, insula, orbitofrontal cortex, entorhinal cortex, and hippocampus were extracted and merged as olfactory regions of interest (ROIs) for further analyses. | Within 1 week after cognitive assessments | |
Primary | Longitudinal changes of cognitive performance | Compare the change of MoCA score from baseline to each follow-up time points (18 months' follow-up, 36 months' follow-up). The Montreal Cognitive Assessment (MoCA) score, ranges from 0 to 30, and higher scores mean better cognition. | From baseline to 18 months' follow-up and 36 months' follow-up | |
Primary | Longitudinal changes of olfactory threshold | Compare the change of olfactory threshold tests score from baseline to each follow-up time points (18 months' follow-up, 36 months' follow-up). Olfactory threshold test: score range 1-13.5, which is determined based on a series of binary dilutions of the N-butanol solution in light mineral oil. The higher the score is, the more sensitive the participant is in detecting an odor. Scores of 8-10 were considered normal olfactory sensitivity, whereas scores of 1-3 signified olfactory dysfunction or anosmia, and scores of =10 indicate better olfactory sensitivity. | From baseline to 18 months' follow-up and 36 months' follow-up | |
Primary | Longitudinal changes of olfactory memory | Compare the change of olfactory memory tests score from baseline to each follow-up time points (18 months' follow-up, 36 months' follow-up). Olfactory memory test: Part A: Participants are shown 4 pictures for each odor (10 odors in total), then they need to select what they sniffed. Have a 10-minute break. Part B: Participants sniff 20 different odors, 10 of which are the same odors as in Part A. They need to select the picture and figure out whether the odor is old or new. | From baseline to 18 months' follow-up and 36 months' follow-up | |
Primary | Longitudinal changes of odor-induced brain fMRI activation | Compare the change of odor-induced brain activation beta value from baseline to each follow-up time points (18 months' follow-up, 36 months' follow-up) | From baseline to 18 months' follow-up and 36 months' follow-up | |
Secondary | Baseline brain structural MRI scan | Cortical morphology | Within 1 week after cognitive assessments | |
Secondary | Baseline brain functional MRI scan | Large-scale network functional connectivity | Within 1 week after cognitive assessments | |
Secondary | Longitudinal changes of brain structural MRI scan | Compare the change of cortical morphology from baseline to each follow-up time points (18 months' follow-up, 36 months' follow-up) | From baseline to 18 months' follow-up and 36 months' follow-up | |
Secondary | Longitudinal changes of functional MRI scan | Compare the change of large-scale network functional connectivity from baseline to each follow-up time points (18 months' follow-up, 36 months' follow-up) | From baseline to 18 months' follow-up and 36 months' follow-up |
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