Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment

Nanjing University

Status: Completed

Conditions: Mild Cognitive Impairment; Type 2 Diabetes Mellitus

Treatments: Other: Olfactory Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06327633

ZZ2024

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Olfactory Training Group

Experimental group

Description:

The subjects repeatedly sniffed pleasant scents of rose, lemon, clove, eucalyptus, coffee and cinnamon twice a day, 6-min per time, with focus, until the completion of the study. Meanwhile, all patients will also continue on their existing dose and regimen of glucose- lowering schemes throughout the study. Twice weekly phone calls will be performed to evaluate the blood glucose situation, assess the safety of intervention and confirm the compliance of participants.

Treatment:

Other: Olfactory Training

Control Group

No Intervention group

Description:

The subjects will maintain the original diet and lifestyle, and also continue on their existing dose and regimen of glucose- lowering schemes throughout the study. Phone calls will be made to evaluate the blood glucose situation.