Risk Model of Cognitive Impairment in Diabetes

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School500 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Type 2 Diabetes Mellitus Mild Cognitive Impairment

Interventions

TestsOTHER

Cognitive assessments and olfactory tests

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Glycaemic control measured by blood test.

HbA1c

Time frame: 1 day

Physical assessments.

BMI(body mess index) in kg/m\^2

Time frame: 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.)

Time frame: 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.

Time frame: 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.

Time frame: 1 day

Central Contacts

Bi Yan, MD, PhD

CONTACT

+8602583106666 biyan@nju.edu.cn

Data from ClinicalTrials.gov

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