Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a… (NCT06085703) | Clinical Trial Compass
CompletedNot Applicable
Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial
China24 participantsStarted 2024-04-01
Plain-language summary
This is a prospective, randomized, open label, parallel, 16-week study to explore and evaluate the therapeutic effects of Henagliflozin on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI).
Who can participate
Age range55 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with type 2 diabetes mellitus ;
* Aged: 55 - 75 years ;
* Cognitive function assessment suggests mild cognitive impairment;
* A stable glucose-lowering regimen include Metformin alone or in combination with antidiabetic drugs other than SGLT2 inhibitors or sulfonylureas/glinides, or basic insulin for more than 2 months, and the dose of metformin≥1.0g/d;
* HbA1c: 7 - 10%;
* ≥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 l…
What they're measuring
1
Change of olfactory brain activation by fMRI
Timeframe: from baseline to 16-week follow-up
Trial details
NCT IDNCT06085703
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School