Relationship Between Diabetes and Cognitive Impairment Based on Olfactory Function Assessment and Functional MRI
NCT ID: NCT02738671
Last Updated: 2019-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2016-01-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Type 1 Diabetes Mellitus
These T1DM patients have late diabetes onset.(latent autoimmune diabetes in adult, LADA)
Cognitive assessment
functional magnetic resonance imaging
olfactory function measurement
Type 2 Diabetes Mellitus
A subgroup of these T2DM patients are obesity patients who will have the bariatric surgery. These obese T2DM subjects will undergo a physical exam, cognitive and olfactory test as well as structural and functional brain MRI at baseline and 6 months after their surgery.
Cognitive assessment
functional magnetic resonance imaging
olfactory function measurement
bariatric surgery
Only a subgroup of the subjects will have the bariatric surgery.
Control
A subgroup of these non-diabetic people are obesity patients who will have the bariatric surgery. These obese subjects will undergo a physical exam, cognitive and olfactory test as well as structural and functional brain fMRI at baseline and 6 months after their surgery.
Cognitive assessment
functional magnetic resonance imaging
olfactory function measurement
bariatric surgery
Only a subgroup of the subjects will have the bariatric surgery.
Interventions
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Cognitive assessment
functional magnetic resonance imaging
olfactory function measurement
bariatric surgery
Only a subgroup of the subjects will have the bariatric surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Disease duration \>1 year.
Exclusion Criteria
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.
30 Years
75 Years
ALL
Yes
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Dalong Zhu
Chief Physician
Locations
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at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Countries
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References
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Zhao Q, Maimaitiaili S, Bi Y, Li M, Li X, Li Q, Shen X, Wu M, Fu L, Zhu Z, Zhang X, Chen J, Hu A, Zhang Z, Zhang W, Zhang B. Brain Iron Deposition Alterations in Type 2 Diabetes Mellitus Patients With Mild Cognitive Impairment Based on Quantitative Susceptibility Mapping. J Diabetes. 2025 Jan;17(1):e70052. doi: 10.1111/1753-0407.70052.
Miao Y, Wang J, Zhang B, Zhang W, Xu X, Hou Y, Ding Q, Yu C, Zhang Z, Bi Y, Zhu D. Altered brain spontaneous and synchronization activity in latent autoimmune diabetes in adults: A resting-state functional MRI study. Diabetes Metab Res Rev. 2023 Jan;39(1):e3587. doi: 10.1002/dmrr.3587. Epub 2022 Nov 7.
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.
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.
Other Identifiers
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ZZ2016
Identifier Type: -
Identifier Source: org_study_id
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