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
1 other identifier
observational
250
1 country
1
Brief Summary
The purpose of this study is to explore the relationship between diabetes and cognitive impairment by olfactory function assessment and functional MRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMay 30, 2019
October 1, 2016
3.2 years
February 25, 2016
May 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Participants' personal information
Self-reported information(education in years)
1 day
Glycaemic control measured by blood test.
HbA1c
1 day
Physical assessments.
BMI(body mess index) in kg/m\^2
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.)
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.
1 day
Montreal Cognitive Assessment (MoCA)
The MoCA is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
1 Day
Functional MRI of the brain tracking testing.
1day
Secondary Outcomes (2)
Change form baseline Glycaemic control measured by blood test.
6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
Change from baseline Functional magnetic resonance imagine
6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
Study Arms (3)
Type 1 Diabetes Mellitus
These T1DM patients have late diabetes onset.(latent autoimmune diabetes in adult, LADA)
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.
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.
Interventions
Only a subgroup of the subjects will have the bariatric surgery.
Eligibility Criteria
T1DM(latent autoimmune diabetes in adult,LADA) and T2DM patients.
You may qualify if:
- Have a certain level of education (at least 6 years), able to complete the cognitive assessment;
- Disease duration \>1 year.
You may not qualify if:
- 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);
- Montreal Cognitive Assessment (MoCA,Beijing edition) score of \< 20;
- History of neurologic or psychological illness;
- History of cardiovascular or cerebrovascular disease;
- Abnormal results of thyroid hormones, vitamin B12, and folate.
- 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;
- Left-handed;
- Partial or complete olfactory dysfunction associated with sinusitis,allergic rhinitis, and deviated nasal septum.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008, China
Related Publications (4)
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.
PMID: 39843980DERIVEDMiao 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.
PMID: 36306532DERIVEDZhang 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.
PMID: 33751221DERIVEDZhang 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.
PMID: 31221697DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
February 25, 2016
First Posted
April 14, 2016
Study Start
January 1, 2016
Primary Completion
March 1, 2019
Study Completion
May 1, 2019
Last Updated
May 30, 2019
Record last verified: 2016-10