The Early Warning System for the Diabetic Encephalopathy

NCT02420470 | Recruiting DMC

• 1 other identifier: TDLL-2014086
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes( mainly type II diabetes )lead to the central nervous system (CNS) function impairment, especially the mild cognitive impairment that increased the risk of progression to dementia.The primary objectives are defined according to a hierarchical design: i) to tailor and apply multi-parametric, functional MRI techniques to identify cerebral abnormalities (cerebral biomarkers) in type 2 diabetes mellitus and prodromal diabetes mellitus ; ii) to assess whether these cerebral biomarkers are associated with cognitive decrements;iii) to follow up with the putative prediabetic condition patients to verify whether they can transform into diabetes.

Conditions

Diabetes Mellitus Type 2; Mild Cognitive Impairment; Metabolic Syndrome X

Keywords

diabetes; neural and vessel alteration; prodromal stage

Outcome Measures

Primary Outcomes (1)

• Functional and structural connectivity relationships of multiple brain regions and biomarkers of brain alterations, and the changes in relationships and biomarkers at 2.5 years.

  Differences in macro-structural and micro-structural between patients,prodromal group and healthy controls will be evaluated. These MRI measures include volumetric characteristics (e.g. hyper-intensities, white matter lesions, atrophy, cerebral microbleeds), quantitative measures (e.g. T2 relaxation times, mean diffusivity, fractional anisotropy, mean kurtosis), functional characteristics (e.g. activated regions, cerebral blood flow), network properties (e.g. functional and structural connectivity, graph-theoretical measures).

  subjects will be assessed six times (once half a year, up to 2.5 years )

Secondary Outcomes (4)

• evaluation of obesity and the changes in the state of obesity at 2.5 years

  subjects will be assessed six times (once half a year, up to 2.5 years)

• metabolic characteristics and their changes at 2.5 years

  subjects will be assessed six times (once half a year, up to 2.5 years)

• Mental health and the changes in the scores of the scales at 2.5 years

  subjects will be assessed six times (once half a year, up to 2.5 years)

• Lifestyle and its changes at 2.5 years

  subjects will be assessed six times (once half a year, up to 2.5 years)

Study Arms (3)

healthy control group

fasting plasma glucose(FPG)\<6.11mmol/L，and 2-h plasma glucose(2hPG)\<7.77mmol/L；

prodromal diabetes group

IFG：fasting plasma glucose(FPG) ≥5.6mmol/L (100mg/dl)，and\<7.0mmol/L (126mg/dl)，oral glucose tolerance test(OGTT) 2-h plasma glucose(2hPG) \<7.8 mmol/L ；IGT：oral glucose tolerance test(OGTT) 2-h plasma glucose(2hPG) ≥7.8mmol/L (140mg/dl)，and\<11.1mmol/L (200mg/dl)，fasting plasma glucose(FPG)\< 5.6mmol/L

diabetes group

fasting plasma glucose(FPG)\>7.0mmol/L, or 2-h plasma glucose(2hPG)\>11.1mmol/L

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

prodromal diabetes and early diabetes

You may qualify if:

• without dementia
• Inform Consent Form
• Education time more than 6 years
• blood glucose matches the group standard

You may not qualify if:

• Pregnant woman
• suffer from serious brain disease
• Magnetic resonance contraindications
• lack of compliance
• image quality is too poor to deal with

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (4)

• Hu B, Yu Y, Yu XW, Ni MH, Cui YY, Cao XY, Yang AL, Jin YX, Liang SR, Li SN, Dai P, Wu K, Yan LF, Gao B, Cui GB. Sequence of episodic memory-related behavioral and brain-imaging abnormalities in type 2 diabetes. Nutr Diabetes. 2025 Feb 1;15(1):1. doi: 10.1038/s41387-025-00359-w.

  PMID: 39893169 DERIVED

• Hu B, Yan LF, Sun Q, Yu Y, Zhang J, Dai YJ, Yang Y, Hu YC, Nan HY, Zhang X, Heng CN, Hou JF, Liu QQ, Shao CH, Li F, Zhou KX, Guo H, Cui GB, Wang W. Disturbed neurovascular coupling in type 2 diabetes mellitus patients: Evidence from a comprehensive fMRI analysis. Neuroimage Clin. 2019;22:101802. doi: 10.1016/j.nicl.2019.101802. Epub 2019 Mar 27.

  PMID: 30991623 DERIVED

• Sun Q, Chen GQ, Wang XB, Yu Y, Hu YC, Yan LF, Zhang X, Yang Y, Zhang J, Liu B, Wang CC, Ma Y, Wang W, Han Y, Cui GB. Alterations of White Matter Integrity and Hippocampal Functional Connectivity in Type 2 Diabetes Without Mild Cognitive Impairment. Front Neuroanat. 2018 Mar 20;12:21. doi: 10.3389/fnana.2018.00021. eCollection 2018.

  PMID: 29615873 DERIVED

• Yu Y, Sun Q, Yan LF, Hu YC, Nan HY, Yang Y, Liu ZC, Wang W, Cui GB. Multimodal MRI for early diabetic mild cognitive impairment: study protocol of a prospective diagnostic trial. BMC Med Imaging. 2016 Aug 24;16(1):50. doi: 10.1186/s12880-016-0152-x.

  PMID: 27552827 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction; Metabolic Syndrome; Diabetes Mellitus; Prodromal Symptoms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangbin Cui, professor

  Tang-Du Hospital

  STUDY CHAIR

Central Study Contacts

Guangbin Cui, professor

CONTACT

cgbtd@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 17, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

CN (1)