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Multimodal Risk Factor Graph Mapping, Metabolic Subtyping, and Digital Intelligent Chronic Disease Management for Prediabetes: An Integrated Cohort and Case-Control Clinical Study

Study acronym: DM-PIONEER
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This observational study aims to understand the metabolic characteristics and long-term changes in adults with prediabetes and to identify risk and protective factors associated with progression to diabetes or return to normal glucose regulation. The study will include adults aged 20 to 69 years with prediabetes. The main questions this study aims to answer are: Which clinical characteristics, lifestyle factors, social and environmental factors, and genetic factors are associated with progression or improvement of prediabetes? How do blood glucose levels, pancreatic islet function, and other metabolic indicators change over time in people with prediabetes? Participants will complete questionnaires about their health status and lifestyle at baseline and during follow-up. According to the study schedule, they will also undergo blood glucose and other metabolic assessments, including an oral glucose tolerance test (OGTT). Some participants will undergo additional assessments, such as body composition analysis, liver elasticity measurement, and arterial stiffness testing. Blood, urine, and other biological samples may also be collected for further research. Participants will be followed over time to assess changes in glucose metabolism and lifestyle. Researchers will evaluate factors associated with return to normal glucose regulation, persistent prediabetes, or progression to diabetes. The findings may help improve early identification and personalized management of people at high risk of developing diabetes.
Trial Details
NCT Number NCT07854002
Lead Sponsor Nanjing Medical University
Collaborators: The Affiliated Hospital Of Guizhou Medical University, The First Affiliated Hospital of Zhengzhou University, Suqian First Hospital, Jiangsu Taizhou People's Hospital, The First People's Hospital of Lianyungang, The Second People's Hospital of Huai'an, Wuxi People's Hospital, Nantong First People's Hospital, Yancheng First People's Hospital, The First Hospital of Jilin University, Fujian Medical University Union Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Nanchang University, People's Hospital of Xinjiang Uygur Autonomous Region, Xijing Hospital, Dalian Central Hospital, Xinqiao Hospital of Chongqing, Suzhou Municipal Hospital, Wuhu City Second People's Hospital, Shangrao People's Hospital, The Fourth Affiliated Hospital of Nanjing Medical University, Changzhou Second People's Hospital affiliated with Nanjing Medical University
Conditions
(from sponsor)
Prediabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Impaired Fasting Glucose, Impaired Glucose Tolerance (Prediabetes)
Related terms Diabetes Mellitus, Glucose Intolerance, Insulin Resistance, Metabolic Diseases, Prediabetic State
Enrollment 30,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov