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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-05-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Olfactory Training Group

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.

Group Type EXPERIMENTAL

Olfactory Training

Intervention Type OTHER

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Olfactory Training

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No