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

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ClinicalTrials.gov Identifier: NCT02738671
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Condition or disease Intervention/treatment
Diabetes Mellitus Cognitive Impairment Obesity Behavioral: Cognitive assessment Other: functional magnetic resonance imaging Other: olfactory function measurement Procedure: bariatric surgery

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.
Study Design
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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Start Date : January 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Type 1 Diabetes Mellitus
These T1DM patients have late diabetes onset.(latent autoimmune diabetes in adult, LADA)
 Behavioral: Cognitive assessment
Other: functional magnetic resonance imaging
Other Name: fMRI

Other: 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.
 Behavioral: Cognitive assessment
Other: functional magnetic resonance imaging
Other Name: fMRI

Other: olfactory function measurement
Procedure: 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.
 Behavioral: Cognitive assessment
Other: functional magnetic resonance imaging
Other Name: fMRI

Other: olfactory function measurement
Procedure: bariatric surgery
Only a subgroup of the subjects will have the bariatric surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Participants' personal information [ Time Frame: 1 day ]
    Self-reported information(education in years)

  2. Glycaemic control measured by blood test. [ Time Frame: 1 day ]
    HbA1c

  3. Physical assessments. [ Time Frame: 1 Day ]
    BMI(body mess index) in kg/m^2

  4. Olfactory threshold test [ Time Frame: 1 day ]

    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.)


  5. Olfactory memory test: [ Time Frame: 1 day ]

    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.


  6. Montreal Cognitive Assessment (MoCA) [ Time Frame: 1 Day ]
    The MoCA is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.

  7. Functional MRI of the brain tracking testing. [ Time Frame: 1day ]

Secondary Outcome Measures :
  1. Change form baseline Glycaemic control measured by blood test. [ Time Frame: 6 months after the bariatric surgery (for diabetic and non-diabetic obese patients) ]
    HbA1c

  2. Change from baseline Functional magnetic resonance imagine [ Time Frame: 6 months after the bariatric surgery (for diabetic and non-diabetic obese patients) ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
T1DM(latent autoimmune diabetes in adult,LADA) and T2DM patients.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738671


Locations
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China, Jiangsu
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dalong Zhu, Chief Physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT02738671    
Other Study ID Numbers: ZZ2016
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: October 2016
Keywords provided by Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
functional MRI
olfactory function
bariatric surgery
Additional relevant MeSH terms:
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Diabetes Mellitus
Cognitive Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders