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临床试验/ITMCTR2100004648
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

Shandong Provincial Hospital0 个研究点开始时间: 待定最近更新:
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.

研究者

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