title: Multimodal MRI for early diabetic mild cognitive impairment: study protocol of a prospective diagnostic trial.
abstract: Type 2 diabetes mellitus (T2DM) is a risk factor for dementia. Mild cognitive impairment (MCI), an intermediary state between normal cognition and dementia, often occurs during the prodromal diabetic stage, making early diagnosis and intervention of MCI very important. Latest neuroimaging techniques revealed some underlying microstructure alterations for diabetic MCI, from certain aspects. But there still lacks an integrated multimodal MRI system to detect early neuroimaging changes in diabetic MCI patients. Thus, we intended to conduct a diagnostic trial using multimodal MRI techniques to detect early diabetic MCI that is determined by the Montreal Cognitive Assessment (MoCA).
  
  
  
  In this study, healthy controls, prodromal diabetes and diabetes subjects (53 subjects/group) aged 40-60 years will be recruited from the physical examination center of Tangdu Hospital. The neuroimaging and psychometric measurements will be repeated at a 0.5 year-interval for 2.5 years' follow-up. The primary outcome measures are 1) Microstructural and functional alterations revealed with multimodal MRI scans including structure magnetic resonance imaging (sMRI), resting state functional magnetic resonance imaging (rs-fMRI), diffusion kurtosis imaging (DKI), and three-dimensional pseudo-continuous arterial spin labeling (3D-pCASL); 2) Cognition evaluation with MoCA. The second outcome measures are obesity, metabolic characteristics, lifestyle and quality of life.
  
  
  
  The study will provide evidence for the potential use of multimodal MRI techniques with psychometric evaluation in diagnosing MCI at prodromal diabetic stage so as to help decision making in early intervention and improve the prognosis of T2DM.
  
  
  
  This study has been registered to ClinicalTrials.gov ( NCT02420470 ) on April 2, 2015 and published on July 29, 2015.
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Yu
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China.
authors.forename: Qian
authors.initials: Q
authors.lastname: Sun
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China.
authors.forename: Lin-Feng
authors.initials: LF
authors.lastname: Yan
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China.
authors.forename: Yu-Chuan
authors.initials: YC
authors.lastname: Hu
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China.
authors.forename: Hai-Yan
authors.initials: HY
authors.lastname: Nan
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China.
authors.forename: Zhi-Cheng
authors.initials: ZC
authors.lastname: Liu
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China. wangwen@fmmu.edu.cn.
authors.forename: Wen
authors.identifier: 0000-0001-6473-4888
authors.initials: W
authors.lastname: Wang
authors.affiliation: Department of Radiology, Tangdu Hospital, Fourth Military Medical University, 569 Xinsi Road, Xi'an, 710038, China. cgbtd@126.com.
authors.forename: Guang-Bin
authors.initials: GB
authors.lastname: Cui
mesh_terms: D000328:Adult; D060825:Cognitive Dysfunction / Q000000981:diagnostic imaging* / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000523:psychology*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging / Q000379:methods*; D059906:Neuroimaging / Q000379:methods*; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life; D012307:Risk Factors
keywords: Microstructural alterations; Microvascular alterations; Mild cognitive impairment; Neuroimaging techniques; Prodromal diabetic stage; Type 2 diabetes mellitus