Diabetic kidney disease
Conditions
Interventions
Type 2 Diabetes Mellitus Group (DM):None
Diabetic Kidney Disease Group (DKD):None
Normal Control Group (NC):None
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Type 2 Diabetes Group (DM) Inclusion Criteria (1) Age >= 18 years; (2) Diagnosis of diabetes mellitus referring to the diagnostic criteria in the "Guideline for the prevention and treatment of type 2 diabetes in China (2020 edition)": 1) Typical symptoms of diabetes, including polydipsia, polyuria, polyphagia, and unexplained weight loss; 2) Meeting one or more of the following four criteria: Random plasma glucose >= 11.1 mmol/L; Fasting plasma glucose >= 7.0 mmol/L; 2-hour plasma glucose during oral glucose tolerance test (OGTT) >= 11.1 mmol/L; Glycated hemoglobin (HbA1c) >= 6.5%. For individuals without typical symptoms of diabetes, repeat testing on a different day is required for confirmation (excluding random plasma glucose). 2. Diabetic Kidney Disease Group (DKD) Inclusion Criteria Meeting the diagnostic criteria for diabetic kidney disease in the "Chinese Guidelines for the Prevention and Treatment of Diabetic Kidney Disease (2021 Edition)": When diabetes is clearly identified as the cause of kidney damage and other causes of chronic kidney disease are excluded, DKD can be diagnosed if at least one of the following criteria is met: (1) In the absence of interfering factors, urinary albumin-to-creatinine ratio (UACR) >= 30 mg/g or urinary albumin excretion rate (UAER) >= 30 mg/24h (>= 20 µg/min) in at least 2 out of 3 tests within a period of 3 to 6 months; (2) eGFR < 60 ml/(min·1.73 m^2) persisting for more than 3 months; (3) Renal biopsy findings consistent with the pathological changes of DKD. 3. Normal Control Group (NC) Inclusion Criteria (1) Normal blood glucose: 1) Fasting plasma glucose < 6.1 mmol/L; 2) 2-hour plasma glucose during OGTT < 7.8 mmol/L; (2) Normal renal function.
Exclusion criteria
Exclusion criteria: 1. Type 2 Diabetes Mellitus Group (DM) Exclusion Criteria (1) Other types of diabetes: e.g., Type 1 diabetes, other specific types of diabetes, gestational diabetes mellitus, hyperglycemic state induced by stress; (2) Concomitant diabetic microvascular complications, including diabetic retinopathy, diabetic kidney damage, estimated glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²); (3) Patients who experienced severe acute diabetic complications (such as ketoacidosis, lactic acidosis, hyperosmolar non-ketotic diabetic coma, hypoglycemic coma) within 6 months prior to screening; (4) Concomitant chronic kidney disease due to other etiologies: e.g., nephrotic syndrome, autosomal dominant or autosomal recessive polycystic kidney disease, etc., kidney diseases requiring immunosuppressive therapy, history of dialysis or kidney transplantation; (5) Patients with severe liver, cardiovascular, hematological diseases, malignancies, rheumatic or immune system diseases, etc.; (6) Patients with refractory hypertension, such as primary aldosteronism, Cushing's syndrome, renal artery stenosis, aortic coarctation, obstructive sleep apnea, consumption of foods rich in glycyrrhizin, or use of other drugs that can elevate blood pressure. 2. Diabetic Kidney Disease Group (DKD) Exclusion Criteria (1) Patients who experienced severe acute diabetic complications (such as ketoacidosis, lactic acidosis, hyperosmolar non-ketotic diabetic coma, hypoglycemic coma) within 6 months prior to screening; (2) Chronic kidney disease due to other etiologies: e.g., nephrotic syndrome, autosomal dominant or autosomal recessive polycystic kidney disease, etc., kidney diseases requiring immunosuppressive therapy, history of dialysis or kidney transplantation; (3) Patients with severe liver, cardiovascular, hematological diseases, malignancies, rheumatic or immune system diseases, etc.; (4) Patients with refractory hypertension, such as primary aldosteronism, Cushing's syndrome, renal artery stenosis, aortic coarctation, obstructive sleep apnea, consumption of foods rich in glycyrrhizin, or use of other drugs that can elevate blood pressure. 3. Normal Control Group (NC) Exclusion Criteria (1) Patients with severe liver, cardiovascular, hematological diseases, malignancies, rheumatic or immune system diseases, etc.; (2) Patients with refractory hypertension, such as primary aldosteronism, Cushing's syndrome, renal artery stenosis, aortic coarctation, obstructive sleep apnea, consumption of foods rich in glycyrrhizin, or use of other drugs that can elevate blood pressure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary albumin-to-creatinine ratio;Plasma targeted amino acid metabolome;Urine targeted amino acid metabolome;Safety endpoints (including: complete blood count, urinalysis, liver function tests); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;Hemoglobin A1c;Total cholesterol;Triglycerides;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Serum creatinine;Blood urea nitrogen;Estimated glomerular filtration rate;Urinary kidney injury molecule-1;Urinary neutrophil gelatinase-associated lipocalin;Urinary beta-2 microglobulin;Serum interleukin-6;Serum tumor necrosis factor-alpha;Serum transforming growth factor-beta;Urinary p21;Kidney ß-galactosidase staining; | — |
Countries
China
Contacts
Public ContactQin Guijun
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed