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
|Condition or disease|
|Diabetes Mellitus Type 2 Mild Cognitive Impairment Metabolic Syndrome X|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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
fasting plasma glucose(FPG)>7.0mmol/L, or 2-h plasma glucose(2hPG)>11.1mmol/L
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Contact: Guangbin Cui, firstname.lastname@example.org|
|Xi'an, Shaanxi, China, 710032|
|Contact: Ying Yu, master 029-18191260958 email@example.com|
|Study Chair:||Guangbin Cui, professor||Tang-Du Hospital|