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Clinical Trials/NCT05590442
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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
August 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Sponsor

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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