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Mechanisms of Sphingolipid Metabolism in Diabetic Kidney disease

Mechanisms of Sphingolipid Metabolism in Diabetic Kidney disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124173
Enrollment
Unknown
Registered
2026-05-08
Start date
2026-05-16
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Diabetic kidney disease

Interventions

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Normal Control Group (NC): (1) Normal blood glucose: 1) Fasting blood glucose = 18 years; (2) According to the diagnostic criteria for diabetes in the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)": 1) Typical symptoms of diabetes, including excessive thirst, excessive urination, excessive hunger, and unexplained weight loss; 2) Meeting one or more of the following four criteria: random blood glucose >= 11.1 mmol/L; fasting blood glucose >= 7.0 mmol/L; 2-hour blood glucose after oral glucose tolerance test (OGTT) >= 11.1 mmol/L; glycosylated hemoglobin (HbA1c) >= 6.5%. Those without typical diabetes symptoms need to be re-examined on another day for confirmation (excluding random blood glucose). 3. Diabetic Kidney Disease Group (DKD): This group meets the diagnostic criteria for diabetic kidney disease as stipulated in the "Chinese Guidelines for the Prevention and Treatment of Diabetes-related Kidney Disease (2021 Edition)": After confirming that diabetes is the cause of kidney damage and excluding other causes of chronic kidney disease, at least one of the following conditions can be diagnosed as DKD: (1) In the absence of interfering factors, at least two out of three urine albumin-to-creatinine ratio (UACR) tests conducted within 3 to 6 months are >= 30 mg/g or urinary albumin excretion rate (UAER) >= 30 mg/24h (>= 20 µg/min); (2) eGFR < 60 ml/(min·1.73 m^2) persists for more than 3 months; (3) The pathological changes of DKD are confirmed by renal biopsy.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for the normal control group (NC): (1) Patients with severe liver, cardiovascular, hematological, malignant tumor, rheumatic immune system diseases; (2) Patients with refractory hypertension, such as primary aldosteronism, Cushing's syndrome, renal artery stenosis, aortic stenosis, obstructive sleep apnea, those who consume foods rich in glycyrrhizin, or those who use other drugs that can raise blood pressure. 2. Exclusion criteria for the Type 2 Diabetes Group (DM): (1) Other types of diabetes: such as type 1 diabetes, other special types of diabetes, gestational diabetes, stress-induced hyperglycemic state; (2) Complications of microvascular diabetes, including diabetic retinopathy, diabetic kidney damage, estimated glomerular filtration rate (estimated glomerular filtration rate, eGFR) < 60 ml/(min·1.73 m^2); (3) Patients who have experienced severe acute diabetic complications within 6 months before screening (such as ketoacidosis, lactic acidosis, hyperosmolar non-ketotic diabetic coma, hypoglycemic coma); (4) Chronic kidney disease caused by other etiologies: such as nephrotic syndrome, autosomal dominant or autosomal recessive polycystic kidney disease, kidney diseases requiring immunosuppressant treatment, patients with dialysis or kidney transplantation history; (5) Patients with severe liver, cardiovascular, hematological, malignant tumors, rheumatic immune system diseases; (6) Patients with persistent hypertension, such as primary aldosteronism, Cushing's syndrome, renal artery stenosis, aortic stenosis, obstructive sleep apnea, consuming foods rich in glycyrrhizin, or using other drugs that can raise blood pressure. 3. Exclusion criteria for the diabetic kidney disease group (DKD): (1) Patients who have experienced severe acute diabetic complications within the previous 6 months (such as ketoacidosis, lactic acidosis, hyperosmolar non-ketotic diabetic coma, hypoglycemic coma); (2) Patients with chronic kidney diseases caused by other etiologies, such as nephrotic syndrome, autosomal dominant or autosomal recessive polycystic kidney disease, kidney diseases requiring immunosuppressive therapy, those with a history of dialysis or kidney transplantation; (3) Patients with severe liver, cardiovascular, hematological, malignant tumor, rheumatic immune system diseases; (4) Patients with refractory hypertension, such as primary aldosteronism, Cushing's syndrome, renal artery stenosis, aortic stenosis, obstructive sleep apnea, those consuming foods rich in glycyrrhizin, or those using other drugs that can raise blood pressure.

Design outcomes

Primary

MeasureTime frame
Urine sphingolipid metabolites;Plasma sphingolipid metabolites;UACR;

Secondary

MeasureTime frame
Kidney Nephrin staining;HbA1c;Complete blood count;Fasting plasma glucose;Total cholesterol (TC)?Triglycerides (TG)?High-density lipoprotein cholesterol (HDL-C)?Low-density lipoprotein cholesterol (LDL-C);EGFR;Urinalysis;BUN;Scr;Liver function tests (ALT?AST);Kidney Podocin staining;

Countries

China

Contacts

Public ContactQin Guijun

The First Affiliated Hospital of Zhengzhou University

hyqingj@zzu.edu.cn+86 371 66862927

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026