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Gut Microbiota and Serum Metabolites as Predictors of Glycemic Variability and Outcomes in Diabetic Kidney Disease

NCT07352436 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2026-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Kidney Disease

Sponsors & Collaborators

  • Eighth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-12-30
Completion
2029-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07352436 on ClinicalTrials.gov