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A Prospective Cross-sectional Observational Study on the Association Between H3K14la Levels and Clinical Phenotypes of Diabetic Kidney Disease

The Role of H3K14la in Diabetic Kidney Disease and the Development of an ELISA Kit

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127184
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Kidney Disease

Interventions

Healthy control group:Healthy status without diabetes or kidney disease
Diabetic kidney disease group:Presence of diabetic kidney disease

Sponsors

Ordos Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Diabetic kidney disease group 1. Participants aged 18–90 years, with no restriction on sex. 2. Previously diagnosed with type 2 diabetes mellitus, or diagnosed with type 2 diabetes mellitus during routine clinical care. 3. Diagnosed with diabetic kidney disease or diabetes-related chronic kidney impairment based on clinical diagnosis, eGFR, UACR, and other relevant examinations. 4. Able to cooperate with peripheral blood collection, urine sample collection, and relevant clinical data collection. 5. Voluntarily agree to participate in this study and sign the informed consent form. Healthy control group 1.Participants aged 18–90 years, with no restriction on sex. 2. No history of diabetes mellitus, chronic kidney disease, or other definite serious chronic diseases. 3. No recent acute infection, fever, severe trauma, or major surgery. 4. Able to cooperate with peripheral blood collection, urine sample collection, and basic information collection. 5. Serum creatinine/eGFR at enrollment does not indicate obvious renal dysfunction, UACR does not indicate obvious albuminuria, and HbA1c does not indicate obvious glucose metabolism abnormality. . 6. Voluntarily agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Diabetic kidney disease group 1. Patients with acute infection, severe trauma, recent major surgery, or an obvious acute inflammatory condition. 2. Patients with kidney diseases caused by other definite etiologies, such as primary glomerulonephritis, lupus nephritis, ANCA-associated vasculitis, obstructive nephropathy, polycystic kidney disease, etc. 3. Patients with malignant tumors, severe hepatic insufficiency, severe cardiac insufficiency, or other severe systemic diseases who are considered by the investigator to be unsuitable for enrollment. 4. Patients who have recently received special treatments that may significantly affect immune-inflammatory status or histone modification levels, such as high-dose glucocorticoids, immunosuppressive agents, or anti-tumor therapy. 5. Pregnant or lactating women. 6. Patients with difficulty in blood collection or an obvious risk of bleeding who are considered by the investigator to be unsuitable for peripheral blood collection. 7. Other conditions considered by the investigator to be unsuitable for participation in this study. Healthy control group 1. Previous diagnosis of diabetes mellitus, chronic kidney disease, autoimmune disease, malignant tumor, or severe cardiac, hepatic, renal, or other systemic diseases. 2. Recent acute infection, fever, trauma, surgery, or obvious inflammatory condition. 3. Recent use of high-dose glucocorticoids, immunosuppressive agents, or other medications that may significantly affect immune-inflammatory status. 4. Serum creatinine/eGFR at enrollment indicates obvious renal dysfunction, or UACR indicates obvious albuminuria. 5. HbA1c indicates obvious glucose metabolism abnormality, or the investigator determines that the participant does not meet the requirements for healthy controls based on medical history and examination results. 6. Pregnant or lactating women. 7. Difficulty in blood collection or an obvious risk of bleeding. 8. Other conditions considered by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
H3K14la lactylation level in PBMCs;

Secondary

MeasureTime frame
Blood creatinine, eGFR, UACR, HbA1c;Blood/PBMC transcriptome-related molecular features;

Countries

China

Contacts

Public ContactBoyang Qiao

Ordos Central Hospital

2020203060050@whu.edu.cn+86 477 859 0623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026