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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Physical assessments.
研究概览
简要总结
The purpose of this study is to explore the relationship between diabetes and cognitive impairment by olfactory function assessment and functional MRI.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a certain level of education (at least 6 years), able to complete the cognitive assessment;
- •Disease duration >1 year.
排除标准
- •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.
结局指标
主要结局
Physical assessments.
时间窗: 1 Day
BMI(body mess index) in kg/m\^2
Montreal Cognitive Assessment (MoCA)
时间窗: 1 Day
The MoCA is a cognitive screening test designed to assist Health Professionals in detection of mild cognitive impairment.
Functional MRI of the brain tracking testing.
时间窗: 1day
Participants' personal information
时间窗: 1 day
Self-reported information(education in years)
Olfactory memory test:
时间窗: 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.
Glycaemic control measured by blood test.
时间窗: 1 day
HbA1c
Olfactory threshold test
时间窗: 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.)
次要结局
- Change from baseline Functional magnetic resonance imagine(6 months after the bariatric surgery (for diabetic and non-diabetic obese patients))
- Change form baseline Glycaemic control measured by blood test.(6 months after the bariatric surgery (for diabetic and non-diabetic obese patients))
研究者
Dalong Zhu
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School