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

May 29, 2019 updated by: Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' personal information
Time Frame: 1 day
Self-reported information(education in years)
1 day
Glycaemic control measured by blood test.
Time Frame: 1 day
HbA1c
1 day
Physical assessments.
Time Frame: 1 Day
BMI(body mess index) in kg/m^2
1 Day
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.)
1 day
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.
1 day
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.
1 Day
Functional MRI of the brain tracking testing.
Time Frame: 1day
1day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
Change from baseline Functional magnetic resonance imagine
Time Frame: 6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZZ2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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