Relationship Between Diabetes and Cognitive Impairment Based on Olfactory Function Assessment and Functional MRI

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School250 enrolled

Overview

The purpose of this study is to explore the relationship between diabetes and cognitive impairment by olfactory function assessment and functional MRI.

Previous research has shown both obesity and diabetes are associated with an increased risk of cognitive impairment. Meanwhile, olfactory impairment is associated with incident (amnestic mild cognitive impairment) aMCI and progression from aMCI to (Alzheimer disease) AD dementia. On one hand, in the cross-sectional study, biometric measurements, cognitive assessment, olfactory function and fMRI results are analysed to explore the differences among T1DM patients, T2DM patients and non-diabetic people . One the other hand, in the longitudinal study, changes in olfactory function and fMRI results in diabetic and non-diabetic obese patients both at baseline and 6 months after their bariatric surgery are collected to investigate whether better glucose and weight control benefit brain function.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Diabetes Mellitus Cognitive Impairment Obesity

Interventions

Cognitive assessmentBEHAVIORAL

functional magnetic resonance imagingOTHER

olfactory function measurementOTHER

bariatric surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have a certain level of education (at least 6 years), able to complete the cognitive assessment; 2. Disease duration \>1 year. Exclusion Criteria: 1. Control participants would be excluded if they had a fasting blood glucose level \>7.0 mmol/L; glucose level\> 7.8 mmol/L after oral glucose tolerance test (OGTT); 2. Montreal Cognitive Assessment (MoCA,Beijing edition) score of \< 20; 3. History of neurologic or psychological illness; 4. History of cardiovascular or cerebrovascular disease; 5. Abnormal results of thyroid hormones, vitamin B12, and folate. 6. Metal implants, unable to complete the MR examinations or evidence of cortical infarcts, hemorrhage, or structural brain disease other than atrophy, lacunes, or white matter lesions; 7. Left-handed; 8. Partial or complete olfactory dysfunction associated with sinusitis,allergic rhinitis, and deviated nasal septum.

Locations (1)

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

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Participants' personal information

Self-reported information(education in years)

Time frame: 1 day

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

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)

The MoCA is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.

Time frame: 1 Day

Functional MRI of the brain tracking testing.

Time frame: 1day

Secondary Outcomes

Change form baseline Glycaemic control measured by blood test.

HbA1c

Data from ClinicalTrials.gov

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