ITMCTR2100004648招募中未知
Implementation Plan for Prevention and Treatment of Type 2 Diabetes Mellitus and Its Microvascular Complications with Integrated Chinese and Western Medicine in Shandong Province
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 80(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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