Clinical trial NCT02738671: Relationship Between Diabetes and Cognitive Impairment Based on Olfactory Function Assessment and Functional MRI
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Cognitive Impairment
Obesity
Keywords: functional MRI
olfactory function
bariatric surgery
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: T1DM(latent autoimmune diabetes in adult,LADA) and T2DM patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants' personal information
timeFrame: 1 day
measure: Glycaemic control measured by blood test.
timeFrame: 1 day
measure: Physical assessments.
timeFrame: 1 Day
measure: Olfactory threshold test
timeFrame: 1 day
measure: Olfactory memory test:
timeFrame: 1 day
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 1 Day
measure: Functional MRI of the brain tracking testing.
timeFrame: 1day
Secondary outcomes:
measure: Change form baseline Glycaemic control measured by blood test.
timeFrame: 6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
measure: Change from baseline Functional magnetic resonance imagine
timeFrame: 6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
References:
citation: Zhang W, Gao C, Qing Z, Zhang Z, Bi Y, Zeng W, Zhang B. Hippocampal subfields atrophy contribute more to cognitive impairment in middle-aged patients with type 2 diabetes rather than microvascular lesions. Acta Diabetol. 2021 Aug;58(8):1023-1033. doi: 10.1007/s00592-020-01670-x. Epub 2021 Mar 22.
citation: Zhang Z, Zhang B, Wang X, Zhang X, Yang QX, Qing Z, Zhang W, Zhu D, Bi Y. Olfactory Dysfunction Mediates Adiposity in Cognitive Impairment of Type 2 Diabetes: Insights From Clinical and Functional Neuroimaging Studies. Diabetes Care. 2019 Jul;42(7):1274-1283. doi: 10.2337/dc18-2584. Epub 2019 May 21.