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.
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Adults aged 20 to 69 years will be recruited from participating hospitals, previous cohort populations, and health examination programs. The study population will include individuals with prediabetes and individuals with normal glucose metabolism who serve as a comparison group. Participants with prediabetes will meet at least one criterion for impaired fasting glucose, impaired glucose tolerance, or elevated HbA1c without meeting diagnostic criteria for diabetes. Participants in the normal glucose metabolism group will have normal fasting glucose, 2-hour glucose during a 75-g oral glucose tolerance test, and HbA1c, with no previous diagnosis of diabetes or prediabetes.
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Glycemic status transition
Participants will be classified according to their glycemic status during follow-up as: (1) progression to type 2 diabetes, defined as fasting plasma glucose (FPG) ≥7.0 mmol/L, 2-hour plasma glucose (2h-PG) ≥11.1 mmol/L, or HbA1c ≥6.5%; (2) persistent prediabetes; or (3) reversion to normal glucose regulation, defined as FPG \<6.1 mmol/L and HbA1c \<5.7%. The proportion of participants in each glycemic outcome category will be assessed.
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Nanjing Medical University
Lead sponsor
The Affiliated Hospital Of Guizhou Medical University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Suqian First Hospital
Collaborator
Jiangsu Taizhou People's Hospital
Collaborator
The First People's Hospital of Lianyungang
Collaborator
The Second People's Hospital of Huai'an
Collaborator
Wuxi People's Hospital
Collaborator
Nantong First People's Hospital
Collaborator
Yancheng First People's Hospital
Collaborator
The First Hospital of Jilin University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
People's Hospital of Xinjiang Uygur Autonomous Region
Collaborator
Xijing Hospital
Collaborator
Dalian Central Hospital
Collaborator
Xinqiao Hospital of Chongqing
Collaborator
Suzhou Municipal Hospital
Collaborator
Wuhu City Second People's Hospital
Collaborator
Shangrao People's Hospital
Collaborator
The Fourth Affiliated Hospital of Nanjing Medical University
Collaborator
Changzhou Second People's Hospital affiliated with Nanjing Medical University
Collaborator
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