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Search / Trial NCT06833541

Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease

Launched by THE FIRST AFFILIATED HOSPITAL OF HUNAN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Feb 13, 2025

Trial Information

Current as of November 10, 2025

Recruiting

Keywords

Diabetic Nephropathy Type 2 Type 2 Diabetes Mellitus Chronic Kidney Disease Intestinal Microbiota Metabolomics

ClinConnect Summary

This clinical trial is studying how the gut microbiota, which is the collection of bacteria in our intestines, may play a role in diabetic kidney disease (DKD). DKD is a common condition that affects people with type 2 diabetes and can lead to serious kidney problems. Researchers believe that understanding the gut bacteria and their byproducts could help identify new ways to prevent and treat DKD without the need for invasive procedures like kidney biopsies.

To participate in this study, you need to be between the ages of 18 and 75 and meet specific health guidelines for diabetes and kidney disease. You should not have any recent infections, weight issues, or chronic gastrointestinal diseases. If you join the study, you will help researchers explore how gut health relates to kidney function, which could lead to better treatment options in the future. This trial is currently recruiting participants, and everyone involved will be thoroughly informed about the study and its purpose.

Gender

ALL

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.

About The First Affiliated Hospital Of Hunan University Of Traditional Chinese Medicine

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine is a leading medical institution dedicated to integrating traditional Chinese medicine with modern healthcare practices. As a prominent clinical trial sponsor, the hospital focuses on advancing research in various therapeutic areas, particularly those aligned with traditional Chinese medical principles. With a commitment to high standards of patient care, innovative research methodologies, and interdisciplinary collaboration, the hospital aims to enhance evidence-based practices and contribute to the global understanding of integrative medicine. Through its robust clinical trial programs, the hospital strives to improve patient outcomes and foster advancements in medical science.

Locations

Changsha, Hunan, China

Patients applied

0 patients applied

Trial Officials

Juan Huang, Doctor

Principal Investigator

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Rong Yu, Doctor

Study Director

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported