Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years old and ≤75 years old, gender is not limited.

Complete demographic data.

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).

The patient is informed of the study as approved by the ethics committee.

Disqualifiers

A history of infection or other acute disease within one month prior to enrollment.

Current state of stress.

Other unstable chronic diseases;

A history of acute and chronic gastrointestinal diseases, including acute gastroenteritis, functional gastrointestinal diseases, inflammatory bowel disease, celiac disease, and other chronic gastrointestinal diseases.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

720 Participants
are grouped into 4 trial groups
Group A: Type 2 Diabetes Kidney Disease
Group B: Type 2 Diabetes Mellitus
Group C: Chronic Kidney Disease
Group D: healthy people

Trial outcomes

Primary outcomes

1

UACR

Urine Albumin-to-Creatinine Ratio

Time frame
Complete once at enrollment
2

eGFR

Estimated Glomerular Filtration Rate

Time frame
Complete once at enrollment
3

BUN

blood urea nitrogen

Time frame
Complete once at enrollment
4

Scr

serum creatinine

Time frame
Complete once at enrollment

Secondary outcomes

1

16S rDNA

16S ribosomal DNA identification

Time frame
Complete once at enrollment
2

Targeted Metabolomics

Targeted Metabolomics technology detection

Time frame
Complete once at enrollment
3

Non-targeted metabolomics

Non-targeted metabolomics technology detection

Time frame
Complete once at enrollment
4

mNGS

metagenomic Next Generation Sequencing

Time frame
Complete once at enrollment

Other outcomes

Sponsors and contacts

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