Could your gut bacteria hold the key to protecting your kidneys?
NCT ID NCT06833541
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This study investigates the link between gut bacteria and diabetic kidney disease, a common complication of type 2 diabetes. Researchers will analyze blood, urine, and stool samples from 556 adults with the condition to look for bacterial and metabolic markers. The goal is to understand how gut flora imbalances contribute to kidney damage and to find less invasive ways to detect the disease early, potentially guiding future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Multi-omics analysis (microbiome, metabolomics, genomics) and bacterio-drug interaction control mechanism
- What this could lead to
- If successful, this could identify gut-derived markers for early detection of diabetic kidney disease and point to new strategies that restore gut flora balance to slow kidney damage.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. Findings may not translate into a treatment, and the complex data may not yield clear, actionable markers.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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556 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients are treated at the Department of Endocrinology or the Department of Nephrology in the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, and those who meet the inclusion criteria. At the same time, healthy people who meet the inclusion criteria are recruited through recruitment advertisements.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patient inclusion criteria: 1. Age ≥18 years old and ≤75 years old, gender is not limited. 2. Complete demographic data. 3. Meet the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease (2021 edition), the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 edition), and the Guidelines for the Screening, Diagnosis, Prevention and Treatment of Chronic Kidney Disease (2017 edition). 4. The patient is informed of the study as approved by the ethics committee. Healthy population inclusion criteria: (1) The patient has no known history of infection or risk factors including HIV hepatitis B or C virus syphilis etc. and no current systemic infection; (2) No obesity (body mass index \>30) and/or diabetes no history of chronic kidney disease; (3) Approved by the ethics committee patients were informed about the study. Exclusion criteria: 1. A history of infection or other acute disease within one month prior to enrollment. 2. Current state of stress. 3. Other unstable chronic diseases; 4. A history of acute and chronic gastrointestinal diseases, including acute gastroenteritis, functional gastrointestinal diseases, inflammatory bowel disease, celiac disease, and other chronic gastrointestinal diseases. 5. Individuals who have received systemic antibiotics, immunosuppressants, chemotherapy, or chronic treatment with proton pump inhibitors within the past three months will be excluded from participation. 6. Pregnant or lactating women will also be excluded. 7. Individuals who have participated in other drug clinical trials within the past three months will be excluded. 8. Individuals who suffer from mental illness, intellectual disability, confusion, or other conditions that may interfere with their ability to cooperate with the completion of relevant information collection will also be excluded. Those who were unable to cooperate with the collection of pertinent data were likewise excluded from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, 410007, China
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