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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738671
• Other study ID #: ZZ2016
• Status: Completed
• Start date: January 2016
• Est. completion date: May 2019

Study information

• Verified date: October 2016
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Diabetes Mellitus
• Obesity

Intervention

Behavioral:
• Cognitive assessment

Other:
• functional magnetic resonance imaging

• olfactory function measurement

Procedure:
• bariatric surgery
Only a subgroup of the subjects will have the bariatric surgery.

Locations

Country	Name	City	State
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' personal information	Self-reported information(education in years)	1 day
Primary	Glycaemic control measured by blood test.	HbA1c	1 day
Primary	Physical assessments.	BMI(body mess index) in kg/m^2	1 Day
Primary	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
Primary	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
Primary	Montreal Cognitive Assessment (MoCA)	The MoCA is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.	1 Day
Primary	Functional MRI of the brain tracking testing.		1day
Secondary	Change form baseline Glycaemic control measured by blood test.	HbA1c	6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)
Secondary	Change from baseline Functional magnetic resonance imagine		6 months after the bariatric surgery (for diabetic and non-diabetic obese patients)