Olfactory training effects on brain function in diabetes patients with mild cognitive impairment
A Pilot, Prospective, Randomized, Open Label, Parallel, 4-month Study to Explore and Evaluate the Therapeutic Effects of Olfactory Training on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in T2DM Patients With Mild Cognitive Impairment.
This study is testing if olfactory training can help improve brain function and thinking skills in people with type 2 diabetes who have mild cognitive impairment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (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 | NCT06327633 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of olfactory training on cognitive and olfactory functions in patients with type 2 diabetes mellitus who exhibit mild cognitive impairment. It is a prospective, randomized, open-label trial lasting four months, focusing on how olfactory training can influence brain activation related to odor processing. Participants will undergo assessments of their cognitive abilities and brain function using functional MRI before and after the intervention. The goal is to evaluate whether olfactory training can lead to improvements in cognitive function and brain activity.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 75 with type 2 diabetes and mild cognitive impairment who have been on a stable glucose-lowering regimen.
Not a fit: Patients with normal cognitive function, dementia, or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cognitive function and quality of life for patients with type 2 diabetes and mild cognitive impairment.
How similar studies have performed: While olfactory training has been explored in various contexts, this specific application in T2DM patients with mild cognitive impairment is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with type 2 diabetes mellitus; * Aged: 40 -75 years ; * Cognitive function assessment suggests mild cognitive impairment; * A stable glucose-lowering regimen for more than 2 months; * ≥6 years of education; * Right-handed. Exclusion Criteria: * Cognitive function assessment suggests normal cognition or dementia; * Other dementia related neurological diseases or depression, Mental dysplasia, mania, schizophrenia, etc in the past 2 years; Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc; * 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. * With symptoms of upper respiratory tract infection, including nasal congestion, runny nose, fever, etc. on the day of MR examination; * Diabetic Acute and chronic complications, including diabetic ketoacidosis, diabetic ketoacidosis; a hyperglycemic hyperosmolar state or severe hypoglycemic coma, etc. * Severe impairment of heart, liver, kidney and other organs; * Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, etc; * Pregnant and lactating women; * Receive other test drugs currently or within 3 months before participating in the project; * Known or suspected allergic history to essential oil; * Taking cognitive-related drugs.
Where this trial is running
Nanjing, Jiangsu
- Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
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.