NCT07352436Not yet recruiting
Gut Microbiota and Serum Metabolites as Predictors of Glycemic Variability and Outcomes in Diabetic Kidney Disease
Prospective Cohort Study on the Impact of Gut Microbiota and Serum Metabolites on Glycemic Variability and Clinical Outcomes in Patients With Diabetic Kidney Disease
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 270 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07352436
What you commit to
- Study type: Observational
- Planned participants: 270
- From 1 Feb 2026 to the primary completion date, 30 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Recent Probiotic or Antibiotic Use:
- Participants who have used probiotics or prebiotics, or received antibiotic treatment for more than 3 days in the past 3 months, or have consumed yogurt or yogurt-containing foods/beverages in the past week.
Other illness
- 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.
- Severe Dermatologic Conditions:
- Participants with severe dermatologic conditions, such as extensive eczema, widespread scars, tattoos, herpetic dermatitis, severe edema, or psoriasis.
- 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.
Other
- Pregnancy or Lactation:
- Women who are pregnant, breastfeeding, or planning to become pregnant in the next month.
Who the study is looking for
- 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. -
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.