Efficacy and Safety of Jinshuibao Capsule as Add-on Therapy to Angiotensin II Receptor Blockers on Diabetic Kidney Disease in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Change in urine albumin creatine ratio (ACR).
研究概览
简要总结
The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.
详细描述
Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including ACEI and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot completely block its development. Cordyceps sinensis is a traditional Chinese medicine and Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However, its clinical application in diabetic kidney disease is not well-defined so far. The aim of this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with written informed consent.
- •Type 2 diabetes according to 1999 WHO criteria.
- •Age: 30-75 years.
- •HbA1c < 11%.
- •Stage III diabetic kidney disease:
- •5.1 microalbuminuria: 30 mg / g < urinary albumin creatinine ratio (ACR) < 300 mg / g, positive for at least two in three times.
- •5.2 renal function: eGFR ≧ 30 ml / min / 1.73 ㎡.
- •Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months.
- •Childbearing-age women with contraceptive measures.
- •Exclusion Criteria：
- •Type 1 Diabetes Mellitus.
- •Non-diabetic urinary system diseases (Urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.)
- •Other serious diseases [severe hypertension ((defined as SBP > 200 mmHg and/or DBP > 110 mmHg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x UNL), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.]
- •Allergic to Cordyceps sinensis, use of ACEIs, any use of Cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc.
- •Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.
- •Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.
排除标准
- 未提供
研究组 & 干预措施
Treatment Group
Treatment：subjects receive Jinshuibao Capsule. ARB will be continued as a routine therapy.
Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling
干预措施: Jinshuibao Capsule (Drug)
结局指标
主要结局
Change in urine albumin creatine ratio (ACR).
时间窗: Baseline and 1,2,3,6 months.
First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial).
次要结局
- Change in urine α1-microglobulin.(Baseline and 1,2,3,6 months.)
- The incidence of ≧30% decline in eGFR from baseline.(half a year)
- Life quality evaluation(Baseline and 6 months.)
- Change in urine N-acetyl-β-D-glucosidase.(Baseline and 1,2,3,6 months.)
- Change in urine neutrophil gelatinase-associated lipocalin.(Baseline and 1,2,3,6 months.)
- Change in inflammation level.(Baseline and 1,2,3,6 months.)
- Change in HbA1c.(Baseline and 1,3,6 months.)
- Change in blood lipids.(Baseline and 1,3,6 months.)
- Incidence of Treatment-Emergent Adverse Events(half a year)
- Change in urine β2-microglobulin.(Baseline and 1,2,3,6 months.)
- Change in blood pressure control.(Baseline and 1,2,3,6 months.)
研究者
Zhiguang Zhou
Head of Endocrinology Department
Second Xiangya Hospital of Central South University