NCT05590442
Recruiting
N/A
Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country500 target enrollmentSeptember 1, 2022
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- The rate of mild cognitive impairment occurrence
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with type 2 diabetes mellitus ;
- •Aged:40 -80 years ;
- •Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30;
Exclusion Criteria
- •Mini-mental State Examination(MMSE) scores \< 24;
- •Other dementia related neurological diseases or depression, schizophrenia in the past 2 years;
- •Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction;
- •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;
- •Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or severe hypoglycemic coma.
Outcomes
Primary Outcomes
The rate of mild cognitive impairment occurrence
Time Frame: 1 year
The rate of Montreal Cognitive Assessment(MoCA) scores less than 26 points after 1 year's follow-up.
Secondary Outcomes
- Olfactory threshold test(1 day)
- Olfactory memory test(1 day)
- Montreal Cognitive Assessment (MoCA) score(1 day)
- Glycaemic control measured by blood test.(1 day)
- Physical assessments.(1 day)
Study Sites (1)
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