Type 2 diabetes mellitus complicated with early diabetic kidney disease (DKD)
Conditions
Interventions
Sangzhi alkaloids group:For the first 4 weeks, take 1 tablet of total alkaloids from Mulberry branches each time, 50mg per tablet. After the follow-up in the 5th week, adjust the dosage to 2 tablets o
Sponsors
Luoyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–70 years (inclusive), both males and females; 2.Diagnosed with type 2 diabetes mellitus according to WHO diagnostic criteria; 3.7% 60 mL/(min·1.73 m^2) and normal serum creatinine; 5.For monotherapy cases: Patients with type 2 diabetes who have not used any antidiabetic drugs at screening, or have used antidiabetic drugs irregularly within 3 months prior to screening (cumulative use =3 months of diet and exercise intervention. For combination therapy cases: Patients who have been on a stable daily dose of antidiabetic agents for at least 6 weeks prior to screening (limited to metformin, sulfonylureas, DPP-4 inhibitors, or basal insulin as monotherapy, or dual therapy containing metformin plus any of the above agents). During the study, if glycemic control is inadequate, adjustments in the type, frequency, or dose of combination agents may be made at the investigator’s discretion (generally the selected agents are limited to metformin, sulfonylureas, DPP-4 inhibitors, or basal insulin as monotherapy, or dual therapy containing metformin plus any of the above agents; dosing frequency: metformin generally 2–3 times daily, sulfonylureas usually taken before meals, DPP-4 inhibitors generally once daily, basal insulin generally once daily at a fixed time; dose adjustments should be made gradually based on the patient’s blood glucose monitoring results and HbA1c levels, following the principle of stepwise titration). 6.Subjects voluntarily participate in the study, sign the informed consent form, have good compliance, and are able to comply with follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with renal artery stenosis and renovascular hypertension; 2.Patients who are pregnant or lactating; 3.Patients with severe cardiopulmonary diseases or chronic liver/kidney dysfunction, including those with ALT/AST > 3× the upper limit of normal; 4.Patients who are allergic to any component of the investigational product or have an allergic constitution; 5.Patients with a history of critical illnesses such as malignant hypertension, myocardial infarction, cerebrovascular accident, or diabetic ketoacidosis within the past six months, or patients with congestive heart failure (Class I–IV), or patients with chronic diarrhea; 6.Patients with elevated urinary microalbumin or urinary protein excretion rate due to primary or secondary kidney diseases (such as chronic nephritis, hypertension, gout, systemic lupus erythematosus, etc.); 7.Patients who have used similar products within 1 month prior to enrollment; 8.Patients who are considered by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change value of glycated hemoglobin (HbA1c) level compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the level of high-sensitivity C-reactive protein (hs-CRP) relative to the baseline;The change in the urine albumin/creatinine ratio (UACR) relative to the baseline;The change in fasting venous blood glucose relative to the baseline;The change in urine ß2-microglobulin (ß2-MG) levels relative to the baseline;Adverse event; | — |
Countries
China
Contacts
Public ContactZhang Yanfang
Luoyang Central Hospital
Outcome results
None listed