Actively Recruiting
Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease
Led by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine · Updated on 2025-02-18
720
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Lead Sponsor
N
National Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Complete demographic data
- Meet diagnostic criteria for diabetic kidney disease, type 2 diabetes, or chronic kidney disease according to Chinese guidelines
- Informed consent approved by ethics committee
- For healthy participants: no infection history or risk factors like HIV, hepatitis B or C, syphilis, or current systemic infection
- For healthy participants: no obesity (BMI >30), diabetes, or chronic kidney disease
- Healthy participants must be informed and approved by ethics committee
You will not qualify if you...
- History of infection or acute disease within one month before enrollment
- Current stress state
- Unstable chronic diseases
- History of acute or chronic gastrointestinal diseases including gastroenteritis, functional disorders, inflammatory bowel disease, celiac disease
- Use of systemic antibiotics, immunosuppressants, chemotherapy, or proton pump inhibitors in past three months
- Pregnant or lactating women
- Participation in other drug clinical trials within past three months
- Mental illness, intellectual disability, confusion, or inability to cooperate with data collection
- Unable to cooperate with data collection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China, 410007
Actively Recruiting
Research Team
X
Xiang ning Huang, Doctor
CONTACT
N
Na Tian, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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