Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease

NCT06833541 | Recruiting

• 1 other identifier: U21A20411
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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 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

Diabetic Nephropathy Type 2; Type 2 Diabetes Mellitus (T2DM); Chronic Kidney Disease

Keywords

Diabetic Nephropathy Type 2; Type 2 diabetes mellitus; chronic kidney disease; intestinal microbiota; metabolomics

Outcome Measures

Primary Outcomes (7)

• UACR

  Urine Albumin-to-Creatinine Ratio

  Complete once at enrollment

• eGFR

  Estimated Glomerular Filtration Rate

  Complete once at enrollment

• BUN

  blood urea nitrogen

  Complete once at enrollment

• Scr

  serum creatinine

  Complete once at enrollment

• FBG

  fasting blood glucose

  Complete once at enrollment

• HbA1c

  Glycosylated Hemoglobin, Type A1C

  Complete once at enrollment

• GSP

  glucosylated serum protein

  Complete once at enrollment

Secondary Outcomes (4)

• 16S rDNA

  Complete once at enrollment

• Targeted Metabolomics

  Complete once at enrollment

• Non-targeted metabolomics

  Complete once at enrollment

• mNGS

  Complete once at enrollment

Study Arms (4)

Type 2 Diabetes Kidney Disease

Clinical diagnostic criteria consistent with Type 2 Diabetes Kidney Disease

Type 2 Diabetes Mellitus

Clinical diagnostic criteria consistent with Type 2 Diabetes Mellitus(T2DM)

Chronic Kidney Disease

Clinical diagnostic criteria consistent with Chronic Kidney Disease (CKD)

healthy people

Relatively healthy people without diabetes and chronic kidney disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Pregnant or lactating women will also be excluded.
• Individuals who have participated in other drug clinical trials within the past three months will be excluded.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Changsha, Hunan, 410007, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, urine supernatant, feces, tongue coating

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Huang, Doctor

  The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Rong Yu, Doctor

  The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Xiang ning Huang, Doctor

CONTACT

86-18229942526; yirenxinlu@foxmail.com

Na Tian, Doctor

CONTACT

86-18374807942; 819062608@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: April 18, 2022
• Primary Completion: February 28, 2025
• Study Completion: December 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)