Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03164785|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2017
Last Update Posted : October 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Diabetic Kidney Disease||Drug: Jinshuibao Capsule||Phase 2 Phase 3|
Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Insulin has been used as a routine therapy for AIDM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. GLP-1 analog Liraglutide has been tested in large-scale clinical trial to prove its various benefits for beta cells and glucolipid metabolism in T2D and obesity patients. However, its clinical application in AIDM is not well-defined so far. The aim of this study is to investigate the potential use of Liraglutide on glycemic control in AIDM.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||April 2019|
Experimental: 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
Drug: Jinshuibao Capsule
1.98g t.i.d. p.o. for 6 months
No Intervention: Control Group
Patients receive a standard dose of ARB drug as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling
- Change in urine albumin creatine ratio (ACR). [ Time Frame: 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).
- The incidence of ≧30% decline in eGFR from baseline. [ Time Frame: half a year ]Monitoring changes in glomerular functions measured in estimated glomerular filtration rate (eGFR) [CKD-EPI creatinine-cystatin equation (2012)].
- Change in urine α1-microglobulin. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in urine β2-microglobulin. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in urine N-acetyl-β-D-glucosidase. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in urine neutrophil gelatinase-associated lipocalin. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in inflammation level. [ Time Frame: Baseline and 1,2,3,6 months. ]Change in hs-CRP level.
- Change in HbA1c. [ Time Frame: Baseline and 1,3,6 months. ]
- Change in blood pressure control. [ Time Frame: Baseline and 1,2,3,6 months. ]
- Change in blood lipids. [ Time Frame: Baseline and 1,3,6 months. ]
- Life quality evaluation [ Time Frame: Baseline and 6 months. ]Change in SF-36 Scale score.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: half a year ]Treatment-related adverse events as assessed by deterioration of liver functions with other reasons excluded, self-report of gastrointestinal symptoms associated with drug intake, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164785
|Contact: Zhiguang Zhou, MD/PhDemail@example.com|
|Principal Investigator:||Zhiguang Zhou, MD/PhD||Second Xiangya Hospital, Central South University|