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Completed

NCT Number: NCT02738671

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

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

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Key information

Conditions

Diabetes Mellitus Body Weight Cognition Disorders Cognitive Dysfunction Cognitive Impairment Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210008, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Cognitive assessment

Behavioral

functional magnetic resonance imaging

Other

Other names: fMRI

olfactory function measurement

Other

bariatric surgery

Procedure

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2016
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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