Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, open label, parallel,6-month 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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Treatments: Gliclazide; Metformin

Criteria

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 lactating women;

• Receive other test drugs currently or within 3 months before participating in the project;

• Known or suspected allergic history to the test drug or similar drugs; SGLT2 inhibitor and sulfonylureas/glinides were used in recent 3 months.