Risk Model of Cognitive Impairment in Diabetes

Study Overview
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Brief Summary
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Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.

Official Title
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Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes

Conditions
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Type 2 Diabetes Mellitus, Mild Cognitive Impairment

Intervention / Treatment
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* Other: Tests


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training cohort<br>The patients will be divided into the training and validation cohorts with a ratio of 7:3. The training cohort will be used to screen variables and construct the model. | Other: Tests<br>* Cognitive assessments and olfactory tests<br>|
| Validation cohort<br>The validation cohort will be used to validate the results obtained using the training cohort. | Other: Tests<br>* Cognitive assessments and olfactory tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of mild cognitive impairment occurrence | The rate of Montreal Cognitive Assessment(MoCA) scores less than 26 points after 1 year's follow-up. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control measured by blood test. | HbA1c | 1 day | 
| Physical assessments. | BMI(body mess index) in kg/m^2 | 1 day | 
| Olfactory threshold test | The same odor with 2 different concentrations are given to the participant each time to find out which one is more intense. (Olfactory software will analyse and give threshold score depending on participant's choice.) | 1 day | 
| Olfactory memory test | PART A: Participants are shown 4 pictures for each odor(10 odors in total). They select what they sniffed. 10 minutes break. PART B: Participants sniff 20 different odors , 10 of which are same odors in PART A. They select the picture and figure out whether the odor is old or new. | 1 day | 
| Montreal Cognitive Assessment (MoCA) score | The MoCA is a cognitive screening test designed to assist health professionals in detection of mild cognitive impairment. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Assessments, Olfactory Test, Risk Model