Status:
COMPLETED
Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Type 2 Diabetes Mellitus
Mild Cognitive Impairment
Eligibility:
All Genders
55-75 years
Phase:
NA
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06085703
Start Date
April 1 2024
End Date
June 30 2025
Last Update
July 10 2025
Active Locations (1)
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1
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008