NCT06833541 Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease
| NCT ID | NCT06833541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine |
| Condition | Diabetic Nephropathy Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 720 participants |
| Start Date | 2022-04-18 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 720 participants in total. It began in 2022-04-18 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Diabetic kidney disease (DKD) is characterized by high prevalence, multiple pathogenesis, and lack of effective treatment and management strategies. Early detection helps overcome treatment inertia, enables timely medical intervention, maximizes renal function in diabetic patients, and is essential to avoid renal failure and improve clinical outcomes. The gold standard for diagnosis of DKD is renal biopsy, which has the highest accuracy. However, due to the trauma of renal biopsy, the patient acceptance is low, the application scenario is not universal, and it is only used when it is difficult to distinguish diabetic nephropathy from non-diabetic nephropathy, and it is not the preferred diagnostic method for DKD. In the past decade, with the emergence and application of metabonomics, proteomics, genomics and other multi-omics techniques, more and more studies have recognized the prominent role of intestinal flora disorders and gut-derived metabolites in the occurrence of DKD. Therefore, from the perspective of intestinal flora, using multi-omics techniques to identify enterogenic metabolic markers of DKD and restore intestinal flora balance may be potential strategies for prevention and management of DKD. Modern medicine believes that intestinal flora is not only closely related to diet and digestion, participating in the synthesis, absorption and metabolism of nutrients, but also constituting intestinal barrier and participating in immune defense of the body. Its function is similar to the physiological function of "The spleen governs transportation and transformation". Based on the traditional Chinese medicine（TCM） pathogenesis of DKD "Spleen Failure to Disperse Essence and Poison Damage Kidney Collateral" proposed by the previous research group, this study intends to use microbiology-metabolomics to deeply study the TCM pathogenesis of DKD, provide scientific basis for it, and guide the theory of traditional Chinese medicine widely used in clinical work of prevention and treatment of diabetic nephropathy.
Eligibility Criteria
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.
Contact & Investigator
Juan Huang, Doctor
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT06833541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diabetic Nephropathy Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06833541 currently recruiting?
Yes, NCT06833541 is actively recruiting participants. Contact the research team at yirenxinlu@foxmail.com for enrollment information.
Where is the NCT06833541 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06833541 clinical trial?
NCT06833541 is sponsored by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine. The principal investigator is Juan Huang, Doctor at The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine. The trial plans to enroll 720 participants.