Diabetic Kidney DiseaseNCT07352436
Gut Microbiota and Serum Metabolites as Predictors of Glycemic Variability and Outcomes in Diabetic Kidney Disease
An observational study of Diabetic Kidney Disease, run by Eighth Affiliated Hospital, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Kidney Disease
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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. -
Who cannot join
- 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.
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- 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:
- 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.
About this study
Official title: Prospective Cohort Study on the Impact of Gut Microbiota and Serum Metabolites on Glycemic Variability and Clinical Outcomes in Patients With Diabetic Kidney Disease
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.
Read the detailed description
Diabetic kidney disease (DKD) is a major microvascular complication of diabetes and a leading cause of end-stage kidney disease. Blood glucose variability (GV) has been shown to be closely associated with disease progression in individuals with DKD. Recent studies suggest that gut microbiota and their serum metabolites may play important roles in regulating GV and influencing clinical outcomes. However, it remains unclear whether gut microbiota and serum metabolites affect DKD progression through GV.
This prospective observational cohort study aims to address three key questions:
- Characterize gut microbiota and serum metabolites in individuals with DKD at different disease stages and severities, and evaluate their prognostic value for adverse outcomes.
- Examine the relationships among gut microbiota, serum metabolites, and blood glucose variability.
- Determine whether gut microbiota and serum metabolites influence clinical outcomes by affecting blood glucose variability.
- A total of 270 individuals with DKD will be enrolled. The investigators will conduct continuous glucose monitoring (CGM), collect blood and stool samples, and analyze these samples using 16S rRNA high-throughput sequencing and untargeted serum LC-MS. These data will be used to assess GV, characterize gut microbiota and serum metabolites, and develop predictive models for adverse outcomes in DKD. The study aims to clarify the impact of gut microbiota and blood glucose variability on DKD prognosis and to develop tools for early identification of high-risk individuals, ultimately improving disease management and clinical outcomes.
- Conditions
- Diabetic Kidney Disease
- Keywords
- Diabetic Kidney Disease, Glycemic Variability, Gut Microbiota
- Medical subject headings
- Diabetic Nephropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Cardiovascular mortality is defined as death resulting from heart disease or related cardiovascular complications occurring during the follow-up period.
Measured: 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)
Major adverse cardiovascular events (MACE) are defined as the occurrence of myocardial infarction, stroke, or unstable angina during the follow-up period.
Measured: 12 months (from baseline)
Number of Participants Undergoing Kidney Transplantation
Kidney transplantation is defined as receipt of a kidney transplant procedure during the follow-up period.
Measured: 12 months (from baseline)
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.
Measured: 12 months (from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352436
- Sponsor's protocol ID
- PY-2025-04
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Impact of Gut Microbiota and Serum Metabolites on Glycemic Variability and Clinical Outcomes in Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT07352436
- Acronym / sponsor ID
- PY-2025-04
- Conditions
- Diabetic Kidney Disease
- Keywords
- Diabetic Kidney Disease, Glycemic Variability, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetic kidney disease (DKD) is a major microvascular complication of diabetes and a leading cause of end-stage kidney disease. Blood glucose variability (GV) has been shown to be closely associated with disease progression in individuals with DKD. Recent studies suggest that gut microbiota and their serum metabolites may play important roles in regulating GV and influencing clinical outcomes. However, it remains unclear whether gut microbiota and serum metabolites affect DKD progression through GV.
This prospective observational cohort study aims to address three key questions:
- Characterize gut microbiota and serum metabolites in individuals with DKD at different disease stages and severities, and evaluate their prognostic value for adverse outcomes.
- Examine the relationships among gut microbiota, serum metabolites, and blood glucose variability.
- Determine whether gut microbiota and serum metabolites influence clinical outcomes by affecting blood glucose variability.
- A total of 270 individuals with DKD will be enrolled. The investigators will conduct continuous glucose monitoring (CGM), collect blood and stool samples, and analyze these samples using 16S rRNA high-throughput sequencing and untargeted serum LC-MS. These data will be used to assess GV, characterize gut microbiota and serum metabolites, and develop predictive models for adverse outcomes in DKD. The study aims to clarify the impact of gut microbiota and blood glucose variability on DKD prognosis and to develop tools for early identification of high-risk individuals, ultimately improving disease management and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Diabetic Kidney Disease (DKD) Progression
Time frame: 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.
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.
4 secondary outcomes
Number of Participants with Cardiovascular Mortality
Time frame: 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)
Time frame: 12 months (from baseline)
Number of Participants Undergoing Kidney Transplantation
Time frame: 12 months (from baseline)
Number of Participants with Hypoglycemic Events
Time frame: 12 months (from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease, run by Eighth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Diabetic Kidney Disease (DKD) Progression (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.