Type 2 Diabetes Mellitus, Mild Cognitive Impairment
Conditions
Keywords
Functional MRI, Cognition, Olfactory training
Brief summary
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).
Interventions
OTHEROlfactory 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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of cognitive function (evaluated by MoCA score) | from baseline to 4-month follow-up | Whether MoCA scores in the two groups of Type 2 diabetes mellitus patients with MCI after intervention were different from those before treatment and the difference of changes between the two groups. The MoCA scale evaluates overall cognitive function, with a total score of 30. Generally, subjects scoring ≥26 points are considered as normal cognition, while between 19-25 points as mild cognitive impairment. An extra point is added If the subject has less than 12 years of education. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of olfactory brain activation by fMRI | from baseline to 4-month follow-up | Whether the activation degree of olfactory task fMRI brain area in the two groups after intervention was different from that before treatment and the difference of changes between the two groups. All patients underwent odor-induced task fMRI on a 3.0T MR scanner with 222 volumes for task fMRI and 230 volumes for resting-state fMRI. The odor-induced task consisted of fresh air rest and scent. Odor-induced brain activation was assessed by a general linear model using Statistical Parametric Mapping 12 (SPM12) software. Following extraction of the three separate conditions fresh air, scent, and rest from the whole sequence, contrasts were made for each participant between fresh air > rest and scent > rest. Odor-induced fMRI data were analyzed in the mask of the olfactory network, including the regions of bilateral parahippocampus, amygdala, piriform cortex, insula, orbitofrontal cortex, hippocampus, and entorhinal cortices. |
| Change of Olfactory function | from baseline to 4-month follow-up | Whether the scores of olfactory threshold, identification and memory of the two groups after intervention were higher than those before treatment and the difference of changes between the two groups. Olfactory testing was performed using Olfactory Function Assessment by Computerized Testing (OLFACT) (Osmic Enterprises, Inc.). Based on the University of Pennsylvania Smell Identification Test (UPSIT), OLFACT tests were computerized, standardized, and self-administered. Higher scores indicated better ability to detect odors. Threshold testing was performed by a series of binary dilutions of n- butanol solution in light mineral oil, and scores ranged from 1 to 14. Identification and memory tests included two tasks: task A with 10 different odors, and task B with 20 odors (with 10 same odors in the task A). Each participant was asked to identify each odor from four pictures in tasks A and B and to indicate whether each was old or new in task B. There was a 10-min break in-between. |
| Change of metabolism | from baseline to 4-month follow-up | The changes of glycosylated hemoglobin among the two groups before and after intervention. The level of glycosylated hemoglobin <7% means better glucose metabolism. |
Countries
China
Outcome results
None listed