Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008, China
NCT Number: NCT06327633
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).
Looking for future studies?
Notify Me40 year–75 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210008, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05313529
Cognition Disorders, Cognitive Dysfunction
Changzhou, Jiangsu, China
View Trial DetailsNCT06085703
Cognition Disorders, Cognitive Dysfunction
Nanjing, Jiangsu, China
View Trial DetailsNCT06401733
Body Weight, Brain Diseases
Singapore
View Trial DetailsNCT07711171
Cognition Disorders, Cognitive Dysfunction
Shanghai, Shanghai Municipality, China
View Trial Details