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The Early Warning System for the Diabetic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02420470
Recruitment Status : Unknown
Verified March 2017 by Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : April 17, 2015
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

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.

Condition or disease
Diabetes Mellitus Type 2 Mild Cognitive Impairment Metabolic Syndrome X

Detailed Description:
Diabetes ( mainly type II diabetes ) lead to the central nervous system (CNS) function impairment, especially the mild cognitive impairment (MCI) that increased the risk of progression to dementia. It was regarded that neurodegeneration contributes to the diabetic MCI, however, recent research suggested that CNS microvascular alterations are the mechanism for early diabetic MCI. But there still lacks an early warning system for the CNS micro-structure alterations during early diabetes. Latest neuroimaging techniques enable the measurement of brain blood flow, local neural activity,and the nuclei deposition of iron to reflect CNS micro-structure alterations. But these techniques are complicated and can not fully reflect the alterations with one single technique.We previous observed that 44.4% of diabetic patients demonstrate MCI and established the comprehensive protocols of measuring brain blood flow, local neural activity and the nuclei deposition of iron simultaneously based on the multimodal MRI technique so as to reflect the microstructure alterations reliably and validly. Therefore, we intend to integrate psychological measurement and clinical biochemical examination, and to establish the early warning system for the central nervous system micro-structure alterations during early diabetes based on the multi-modal MRI technique. The reliability and validity of this system will be tested in the diabetic rat model. The early warning system will likely assist in screening patients with diabetic microstructure alterations, to perform early intervention so as to prevent or delay the progression from diabetic MCI to dementia.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Early Warning System for the Central Nervous System Micro-structure Alterations During Early Diabetes Based on the Multi-mode MRIs
Study Start Date : April 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2018


Group/Cohort
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



Primary Outcome Measures :
  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. [ Time Frame: subjects will be assessed six times (once half a year, up to 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).


Secondary Outcome Measures :
  1. evaluation of obesity and the changes in the state of obesity at 2.5 years [ Time Frame: subjects will be assessed six times (once half a year, up to 2.5 years) ]
    Simple evaluation of obesity will include: Body mass index will be calculated as the weight (kg) divided by the square of the height (m). Waist circumference (WC) will be taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.

  2. metabolic characteristics and their changes at 2.5 years [ Time Frame: subjects will be assessed six times (once half a year, up to 2.5 years) ]
    Simple metabolic characteristics will include: oral glucose tolerance test, C peptide releasing test and insulin releasing test will be assessed;homeostasis model assessment of insulin resistance,insulin secretion of homeostasis model assessment and homeostasis model assessment-β will be calculated. what`s more, cardiovascular risk factors(e.g. albumin, creatinin, total cholesterol, LDL- and HDL-cholesterol, triglycerides, HbA1c) will be assessed.

  3. Mental health and the changes in the scores of the scales at 2.5 years [ Time Frame: subjects will be assessed six times (once half a year, up to 2.5 years) ]
    To evaluate the mental health, a series of psychiatric evaluation scale(e.g. mini-mental state examination, Montreal Cognitive Assessment,Hamilton anxiety scale, self-rating depression scale, frontal assessment battery) will be assessed.

  4. Lifestyle and its changes at 2.5 years [ Time Frame: subjects will be assessed six times (once half a year, up to 2.5 years) ]
    Lifestyle specifics, including alcohol consumption, smoking behavior and mobility and exercise habit will be obtained. At the same time, quality of life will be obtained through a questionnaire.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
prodromal diabetes and early diabetes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420470


Contacts
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Contact: Guangbin Cui, professor cgbtd@126.com

Locations
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China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ying Yu, master    029-18191260958    yqlmn@126.com   
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Study Chair: Guangbin Cui, professor Tang-Du Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02420470     History of Changes
Other Study ID Numbers: TDLL-2014086
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Tang-Du Hospital:
diabetes
neural and vessel alteration
prodromal stage

Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Cognitive Dysfunction
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Cognition Disorders
Neurocognitive Disorders
Mental Disorders