Effects of Olfactory Training on the Brain Function in T2DM 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 is a 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 (MCI).

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.