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

NCT07352436 | Not Yet Recruiting DMC

• 1 other identifier: PY-2025-04
• Study Type: observational
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Diabetic Kidney Disease; Glycemic Variability; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• 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.

  Time Frame: 12 months (from baseline to endpoint assessment) This time frame reflects the follow-up period during which DKD progression will be monitored in the study cohort.

Secondary Outcomes (4)

• Number of Participants with Cardiovascular Mortality

  Time Frame: 12 months Adverse events will be monitored over a period of 12 months from baseline to track occurrences and assess their relationship with GV and other biomarkers.

• Number of Participants with Major Adverse Cardiovascular Events (MACE)

  12 months (from baseline)

• Number of Participants Undergoing Kidney Transplantation

  12 months (from baseline)

• Number of Participants with Hypoglycemic Events

  12 months (from baseline)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Willingness to Provide Informed Consent:
• Participants must voluntarily sign an informed consent form to participate in the study. -

You may not qualify if:

• Acute Diabetic Complications:
• Participants with acute diabetic complications, such as diabetic ketoacidosis (DKA), or with primary kidney diseases like primary glomerulonephritis, nephrotic syndrome, or lupus nephritis.
• Infection or Stress Conditions:
• Participants in a state of infection, trauma, or other stress conditions.
• Pregnancy or Lactation:
• Women who are pregnant, breastfeeding, or planning to become pregnant in the next month.
• Severe Dermatologic Conditions:
• Participants with severe dermatologic conditions, such as extensive eczema, widespread scars, tattoos, herpetic dermatitis, severe edema, or psoriasis.
• Skin Issues with Sensor Application:
• Participants with severe skin issues at the site of sensor application, such as burns, injuries, sunburns, ulcers, or scars from prior surgery.
• Coagulation or Blood Disorders:
• Participants with abnormal coagulation, anemia, or abnormal hematocrit.
• Chronic Gastrointestinal Diseases or Surgery History:
• Participants with chronic gastrointestinal diseases or a history of gastrointestinal or biliary surgery.
• Recent Probiotic or Antibiotic Use:

Sponsors & Collaborators

• Eighth Affiliated Hospital, Sun Yat-sen University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples，Stool samples

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 30, 2029
• Last Updated: January 20, 2026

Record last verified: 2025-12