NCT06327633
Completed
Not Applicable
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.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country60 target enrollmentStarted: January 1, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change of cognitive function (evaluated by MoCA score)
Overview
Brief Summary
This is 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 (MCI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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, or basic insulin 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;
Outcomes
Primary Outcomes
Change of cognitive function (evaluated by MoCA score)
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.
Secondary Outcomes
- Change of olfactory brain activation by fMRI(from baseline to 4-month follow-up)
- Change of Olfactory function(from baseline to 4-month follow-up)
- Change of metabolism(from baseline to 4-month follow-up)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical TrialType 2 Diabetes MellitusMild Cognitive ImpairmentNCT06085703The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School24
Completed
Phase 4
Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal WomenVasomotor SymptomsNCT00472004Wyeth is now a wholly owned subsidiary of Pfizer204
Unknown
Not Applicable
Effects of Liraglutid, Dapagliflozin and Acarbose on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in Overweight/Obese T2DM Patients Controlled Inadequately With Metformin Monotherapy.Type 2 Diabetes MellitusObesityCognitive ImpairmentNCT03961659The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School87
Unknown
Phase 4
Evaluate the Efficacy of Fenofibrate on MicroalbuminuriaMicroalbuminuriaNCT02314533Beijing Chao Yang Hospital200
Active, not recruiting
Not Applicable
LIGHT-MCI Trial: GLP-1 Agonist, SGLT2 Inhibitor, and DPP-4 Inhibitor for MCI Remission in Type 2 DiabetesType 2 Diabetes MellitusMild Cognitive ImpairmentNCT05313529The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School396