Diabetic kidney disease (DKD) is one of the main complications of diabetes and a leading cause of end-stage kidney disease. Blood glucose variability is closely associated with disease progression in individuals with DKD. Recent evidence suggests that gut bacteria and their circulating metabolites may play important roles in regulating blood glucose variability and clinical outcomes. However, it remains unclear whether gut bacteria and blood metabolites influence DKD progression through effects on blood glucose variability.
This study aims to (1) characterize gut bacteria and blood metabolites in individuals with DKD at different stages and levels of disease severity, and evaluate their value in predicting adverse outcomes; (2) assess the relationships among gut bacteria, blood metabolites, and blood glucose variability; and (3) determine whether gut bacteria and blood metabolites affect clinical outcomes by modulating blood glucose variability.
A total of 270 individuals with DKD will be enrolled in a prospective observational cohort. The investigators will conduct continuous glucose monitoring and collect stool and blood samples for advanced analyses of gut microbiota and blood metabolites. The objective is to clarify how gut bacteria and circulating metabolites relate to blood glucose variability and disease prognosis, and to develop tools to identify high-risk individuals at an early stage. Ultimately, the findings may provide new insights and strategies to improve clinical care and quality of life for individuals with DKD.
Age 18-65 years
Diagnosis of Diabetic Kidney Disease (DKD)
Type 2 Diabetes Mellitus
Stable Antidiabetic Regimen:The antidiabetic regimen must have been stable for at least 3 months prior to study enrollment.
None
The study population will consist of adult patients diagnosed with Diabetic Kidney Disease (DKD), aged between 18 and 65 years. All participants will have a confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM) in accordance with the 1999 World Health Organization diagnostic criteria, and meet the diagnostic criteria for DKD as outlined in the 2021 Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease.
Cohort
Prospective
Not listed
Number of Participants with Diabetic Kidney Disease (DKD) Progression
DKD progression is defined as the occurrence of at least one of the following events: (1) end-stage kidney disease requiring dialysis or kidney transplantation; or (2) a sustained decline of ≥30% in estimated glomerular filtration rate (eGFR) from baseline. This outcome will be used to assess the predictive value of blood glucose variability, gut microbiota, serum metabolites, and inflammatory markers for long-term DKD progression.
Number of Participants with Cardiovascular Mortality
Cardiovascular mortality is defined as death resulting from heart disease or related cardiovascular complications occurring during the follow-up period.
Number of Participants with Major Adverse Cardiovascular Events (MACE)
Major adverse cardiovascular events (MACE) are defined as the occurrence of myocardial infarction, stroke, or unstable angina during the follow-up period.
Number of Participants Undergoing Kidney Transplantation
Kidney transplantation is defined as receipt of a kidney transplant procedure during the follow-up period.
Number of Participants with Hypoglycemic Events
Hypoglycemic events are defined as documented episodes of hypoglycemia occurring during the study period, identified by continuous glucose monitoring and/or clinical records.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
