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

The Cross-sectional and Longitudinal Study of Relationship Between Diabetes and Cognitive Impairment by Olfactory Function Assessment and Functional MRI in Obese and Normal Weight Diabetic Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02738671
Enrollment
250
Registered
2016-04-14
Start date
2016-01-31
Completion date
2019-05-31
Last updated
2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Diabetes Mellitus, Obesity

Keywords

functional MRI, olfactory function, bariatric surgery

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALCognitive assessment
OTHERfunctional magnetic resonance imaging
OTHERolfactory function measurement
PROCEDUREbariatric surgery

Only a subgroup of the subjects will have the bariatric surgery.

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional MRI of the brain tracking testing.1day
Olfactory memory test:1 dayPART 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.
Montreal Cognitive Assessment (MoCA)1 DayThe MoCA is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
Participants' personal information1 daySelf-reported information(education in years)
Glycaemic control measured by blood test.1 dayHbA1c
Physical assessments.1 DayBMI(body mess index) in kg/m\^2
Olfactory threshold test1 dayOlfactory 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.)

Secondary

MeasureTime frameDescription
Change from baseline Functional magnetic resonance imagine6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
Change form baseline Glycaemic control measured by blood test.6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)HbA1c

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026