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Implementation Plan for Prevention and Treatment of Type 2 Diabetes Mellitus and Its Microvascular Complications with Integrated Chinese and Western Medicine in Shandong Province

Implementation Plan for Prevention and Treatment of Type 2 Diabetes Mellitus and Its Microvascular Complications with Integrated Chinese and Western Medicine in Shandong Province

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044774
Enrollment
Unknown
Registered
2021-03-27
Start date
2021-03-27
Completion date
Unknown
Last updated
2021-10-26

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

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.In patients with type 2 diabetic nephropathy, persistent albuminuria, 2 consecutive urine tests within 3 months of urine microalbumin/creatinine (UACR) >= 30mg/g; 2.Glomerular filtration rate eGFR>=45ml/min/1.73m2, and required to remain stable during the trial (eGFR decreased <=25% from the beginning of screening to the second week of follow-up); 3.Patients with deficiency of qi and yin and blood stasis; 4.No gender limit, age 18-80 years old, BMI <= 45 kg/m2; 5.Glycated hemoglobin (HbA1c) 6-11% , fasting blood glucose (FPG) <= 15 mmol/l; 6.Systolic/Diastolic blood pressure (SBP/DBP) <=180/100 mmHg (sitting position); 7.Volunteer to participate and cooperate with physicians, sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Recent acute complications of diabetes such as hypoglycemia coma, diabetic ketosis, lactic acidosis, etc. 2.Patients with heart failure and myocardial infarction; combined infection, immune disease, malignant tumor; combined with liver disease (ALT, AST or ALP levels exceed three times the upper limit of normal); 3.Male serum creatinine (SCr)>= 1.50 mg or Fmale serum creatinine (SCr) >= 1.40 mg; 4.People with a history of nephrotic syndrome or inflammatory kidney disease in the past 3 months, or other causes such as excessive exercise, heart failure, infectious febrile diseases, and urinary tract infections that lead to elevated urine microprotein; 5.Those who have used nephrotoxic drugs and antioxidants within the past 2 weeks, or have been treated with glucocorticoids systemically; 6.Patients requiring dialysis or kidney transplantation; 7.History of bariatric surgery or other gastrointestinal surgery causing chronic malabsorption within 2 years; 8.Patients with drug contraindications: pregnant or breastfeeding women, allergic physiques, and those who are allergic to the drug used in this test; 9.Epidemiological history; 10.Others who cannot cooperate, such as mental patients.

Design outcomes

Primary

MeasureTime frame
urinary albumin-creatinin ration;glomerular filtration rate;

Secondary

MeasureTime frame
serum creatinine;blood urea nitrogen;fasting blood-glucose;glycated hemoglobin;blood lipid profile;liver ultrasound;fundus examination;routine urine test;

Countries

China

Contacts

Public ContactZhao Jiajun

Shandong Provincial Hospital

jjzhao@sdu.edu.cn+86 15168889899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026