Research on gut bacteria and metabolites in diabetic kidney disease
Research on Gut-kidney Axis Regulation of Diabetic Kidney Disease Based on Multi-omics and Bacterio-drug Interaction Control Mechanism
This study is trying to see how gut bacteria and their byproducts affect people with diabetic kidney disease and type 2 diabetes to help improve understanding and diagnosis of the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06833541 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of gut microbiota and metabolites in patients with diabetic kidney disease, type 2 diabetes mellitus, and chronic kidney disease. It will recruit participants based on specific clinical diagnostic criteria and collect various biological samples, including blood, urine, and feces. Advanced techniques such as 16S rDNA sequencing and metabolomics will be employed to analyze the samples and identify differences among the groups. The findings may lead to improved understanding and potential new diagnostic methods for diabetic kidney disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with type 2 diabetes, diabetic kidney disease, chronic kidney disease, or healthy individuals without chronic conditions.
Not a fit: Patients with recent infections or acute diseases, or those with a history of chronic kidney disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into non-invasive diagnostic methods for diabetic kidney disease, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using multi-omics approaches to understand diabetic kidney disease, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Juan Huang, Doctor — The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Study coordinator: Xiang ning Huang, Doctor
- Email: yirenxinlu@foxmail.com
- Phone: 86-18229942526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.