AzTrials
AzTrials

Diabetic Nephropathy Type 2NCT06833541

Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease

An observational study of Diabetic Nephropathy Type 2 and Type 2 Diabetes Mellitus (T2DM), run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
How many people
556 participants
Where
1 siteChina
Study dates
18 Apr 2022to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients are treated at the Department of Endocrinology or the Department of Nephrology in the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, and those who meet the inclusion criteria. At the same time, healthy people who meet the inclusion criteria are recruited through recruitment advertisements.

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

    Changsha, Hunan, 410007

Other trials in China

About this study

Official title: Research on Gut-kidney Axis Regulation of Diabetic Kidney Disease Based on Multi-omics and Bacterio-drug Interaction Control Mechanism

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.

Read the detailed description

This study is a single-center, parallel trial design. It is prepared to recruit subjects with type 2 diabetes kidney disease (DKD), Type 2 diabetes mellitus(T2DM), chronic kidney disease (CKD), and healthy individuals based on clinical diagnostic criteria and screening criteria. While observing main indicators such as blood glucose, glycosylated hemoglobin, and renal function, blood, urine, feces, and tongue coating samples are collected and frozen. The 16S rDNA technology, metagenomics technology, targeted and non-targeted metabolomics technology are used to detect the results and analyze the differences. Subsequently, based on the detection results, 4-6 remaining fecal samples from each group will be selected as human-intestinal flora donors for "human-germ-free mouse" faecal microbiota transplantation.

Keywords
Diabetic Nephropathy Type 2, Type 2 diabetes mellitus, chronic kidney disease, intestinal microbiota, metabolomics
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06833541
Study groupRoleWhat they receive
Type 2 Diabetes Kidney DiseaseClinical diagnostic criteria consistent with Type 2 Diabetes Kidney Disease
Type 2 Diabetes MellitusClinical diagnostic criteria consistent with Type 2 Diabetes Mellitus(T2DM)
Chronic Kidney DiseaseClinical diagnostic criteria consistent with Chronic Kidney Disease (CKD)
healthy peopleRelatively healthy people without diabetes and chronic kidney disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. UACR

    Urine Albumin-to-Creatinine Ratio

    Measured: Complete once at enrollment

  2. eGFR

    Estimated Glomerular Filtration Rate

    Measured: Complete once at enrollment

  3. BUN

    blood urea nitrogen

    Measured: Complete once at enrollment

  4. Scr

    serum creatinine

    Measured: Complete once at enrollment

  5. FBG

    fasting blood glucose

    Measured: Complete once at enrollment

  6. HbA1c

    Glycosylated Hemoglobin, Type A1C

    Measured: Complete once at enrollment

  7. GSP

    glucosylated serum protein

    Measured: Complete once at enrollment

Secondary outcomes (4)

  1. 16S rDNA

    16S ribosomal DNA identification

    Measured: Complete once at enrollment

  2. Targeted Metabolomics

    Targeted Metabolomics technology detection

    Measured: Complete once at enrollment

  3. Non-targeted metabolomics

    Non-targeted metabolomics technology detection

    Measured: Complete once at enrollment

  4. mNGS

    metagenomic Next Generation Sequencing

    Measured: Complete once at enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start18 Apr 2022
  3. Primary completion1 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06833541
Sponsor's protocol ID
U21A20411
Status last verified
Dec 2025
First submitted
13 Feb 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Nephropathy Type 2 and Type 2 Diabetes Mellitus (T2DM), run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

UACR (time frame: Complete once at enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06833541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in