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Diabetes MellitusNCT02738671

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

An observational study of Diabetes Mellitus and Cognitive Impairment, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Cognitive Impairment, Obesity
What is being tested?
Cognitive assessment, functional magnetic resonance imaging and olfactory function measurement
How many people
250 participants
Where
1 siteChina
Study dates
Jan 2016to May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: T1DM(latent autoimmune diabetes in adult,LADA) and T2DM patients.

Who may be able to join

  • Have a certain level of education (at least 6 years), able to complete the cognitive assessment;
  • Disease duration >1 year.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

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

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

Read the 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.

Being tested
Cognitive assessment, functional magnetic resonance imaging, olfactory function measurement, bariatric surgery
Keywords
functional MRI, olfactory function, bariatric surgery
Medical subject headings
Diabetes Mellitus, Cognitive Dysfunction, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive assessmentBehavioural

  • functional magnetic resonance imagingOther

    Also called fMRI

  • olfactory function measurementOther

  • bariatric surgeryProcedure or surgery

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

Study groups in NCT02738671
Study groupRoleWhat they receive
Type 1 Diabetes MellitusThese T1DM patients have late diabetes onset.(latent autoimmune diabetes in adult, LADA)
Receives: Behavioral: Cognitive assessment; Other: functional magnetic resonance imaging; Other: olfactory function measurement
Type 2 Diabetes MellitusA 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.
Receives: Behavioral: Cognitive assessment; Other: functional magnetic resonance imaging; Other: olfactory function measurement; Procedure: bariatric surgery
ControlA 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.
Receives: Behavioral: Cognitive assessment; Other: functional magnetic resonance imaging; Other: olfactory function measurement; Procedure: bariatric surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants' personal information

    Self-reported information(education in years)

    Measured: 1 day

  2. Glycaemic control measured by blood test.

    HbA1c

    Measured: 1 day

  3. Physical assessments.

    BMI(body mess index) in kg/m^2

    Measured: 1 Day

  4. 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.)

    Measured: 1 day

  5. 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.

    Measured: 1 day

  6. Montreal Cognitive Assessment (MoCA)

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

    Measured: 1 Day

  7. Functional MRI of the brain tracking testing.

    Measured: 1day

Secondary outcomes (2)

  1. Change form baseline Glycaemic control measured by blood test.

    HbA1c

    Measured: 6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)

  2. Change from baseline Functional magnetic resonance imagine

    Measured: 6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionMar 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738671
Sponsor's protocol ID
ZZ2016
Status last verified
Oct 2016
First submitted
25 Feb 2016
Last updated
30 May 2019
Results posted
No

Publications

  • 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.

    PubMed 39843980

  • 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.

    PubMed 36306532

  • 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.

    PubMed 33751221

  • 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.

    PubMed 31221697

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Cognitive Impairment, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants' personal information (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738671, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.

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