Diagnostic models for cognitive impairment in diabetes using smell tests and brain scans
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 study is testing if smell tests and brain scans can help find early signs of thinking problems in people with type 2 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05543967 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish diagnostic models that utilize olfactory function assessments and odor-induced brain activation to identify cognitive impairment in patients with type 2 diabetes mellitus. It will involve recruiting 200 patients with diabetes and healthy controls, conducting a series of assessments including cognitive tests, olfactory function measurements, and functional MRI scans. The study will be conducted over three years with follow-ups every 18 months to evaluate changes in cognitive and olfactory parameters. The goal is to identify non-invasive biomarkers for early diagnosis and prognosis of cognitive decline in diabetic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40-75 years with a diagnosis of type 2 diabetes for more than one year.
Not a fit: Patients with acute diseases, significant cognitive impairment, or those with conditions affecting olfactory function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention for cognitive impairment in patients with type 2 diabetes, potentially improving their quality of life.
How similar studies have performed: Previous studies have indicated that olfactory dysfunction and brain activation changes can precede cognitive decline, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Wen Zhang, MD, PhD
- Email: zw7830254@163.com
- Phone: 86-15950576908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.