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

Nanjing University

Status: Completed

Conditions: Cognitive Impairment; Diabetes Mellitus; Obesity

Treatments: Other: functional magnetic resonance imaging; Procedure: bariatric surgery; Other: olfactory function measurement; Behavioral: Cognitive assessment

Study type: Observational

Funder types: Other

Identifiers

NCT02738671

ZZ2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

250 participants in 3 patient groups

Type 1 Diabetes Mellitus

Description:

These T1DM patients have late diabetes onset.(latent autoimmune diabetes in adult, LADA)

Treatment:

Other: olfactory function measurement

Other: functional magnetic resonance imaging

Behavioral: Cognitive assessment

Type 2 Diabetes Mellitus

Description:

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.

Treatment:

Other: olfactory function measurement

Procedure: bariatric surgery

Other: functional magnetic resonance imaging

Behavioral: Cognitive assessment

Control

Description:

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.

Treatment:

Other: olfactory function measurement

Procedure: bariatric surgery

Other: functional magnetic resonance imaging

Behavioral: Cognitive assessment