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NCT06833541
Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease
trial in Diabetic Nephropathy Type 2 in 720 participants. Currently enrolling.
28 February 2025
Quick facts
| Lead sponsor | The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 720 |
| Start date | 18 April 2022 |
| Primary completion | 28 February 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across China |
Conditions studied
- Diabetic Nephropathy Type 2 — all drugs for Diabetic Nephropathy Type 2 →
- Type 2 Diabetes Mellitus (T2DM) — all drugs for Type 2 Diabetes Mellitus (T2DM) →
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
Sponsor
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Who can join
Adults 18 to 75, any sex, with Diabetic Nephropathy Type 2 or Type 2 Diabetes Mellitus (T2DM). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06833541
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06833541 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Last refreshed: 18 February 2025
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