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Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03164785
Recruitment Status : Not yet recruiting
First Posted : May 24, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Zhiguang Zhou, Second Xiangya Hospital of Central South University

Brief Summary:
The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetic Kidney Disease Drug: Jinshuibao Capsule Phase 2 Phase 3

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • Jinshuibao Jiaonang
  • Cordyceps sinensis
  • Artificial Cordyceps sinensis powder

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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)].

  2. Change in urine α1-microglobulin. [ Time Frame: Baseline and 1,2,3,6 months. ]
  3. Change in urine β2-microglobulin. [ Time Frame: Baseline and 1,2,3,6 months. ]
  4. Change in urine N-acetyl-β-D-glucosidase. [ Time Frame: Baseline and 1,2,3,6 months. ]
  5. Change in urine neutrophil gelatinase-associated lipocalin. [ Time Frame: Baseline and 1,2,3,6 months. ]
  6. Change in inflammation level. [ Time Frame: Baseline and 1,2,3,6 months. ]
    Change in hs-CRP level.

  7. Change in HbA1c. [ Time Frame: Baseline and 1,3,6 months. ]
  8. Change in blood pressure control. [ Time Frame: Baseline and 1,2,3,6 months. ]
  9. Change in blood lipids. [ Time Frame: Baseline and 1,3,6 months. ]
  10. Life quality evaluation [ Time Frame: Baseline and 6 months. ]
    Change in SF-36 Scale score.

  11. 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.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with written informed consent.
  2. Type 2 diabetes according to 1999 WHO criteria.
  3. Age: 30-75 years. 4.6.5% < HbA1c < 11%.

5.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 ㎡. 5.3 diabetic retinopathy confirmed by fundus photography . 6.Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months. 7.Childbearing-age women with contraceptive measures.

Exclusion Criteria:

  1. Type 1 Diabetes Mellitus.
  2. 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.)
  3. Other serious diseases [severe hypertension, 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, etc.]
  4. 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.
  5. Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.
  6. Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.

Information from the National Library of Medicine

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


Contacts
Contact: Zhiguang Zhou, MD/PhD 86-731-85292154 zhouzg@hotmail.com

Sponsors and Collaborators
Second Xiangya Hospital of Central South University
Investigators
Principal Investigator: Zhiguang Zhou, MD/PhD Second Xiangya Hospital, Central South University

Responsible Party: Zhiguang Zhou, Head of Endocrinology Department, Second Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03164785     History of Changes
Other Study ID Numbers: JSB201601
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The results belongs to the principal investigator and collaborators.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action