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Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

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. Identifier: NCT03445247
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
In the current study, we use extracorporeal low-intensity shockwave therapy (ESWT) to treat on patients with type 2 diabetes in stage 3-4 chronic kidney disease and see whether it can improve the proteinuria, renal function, and blood pressure compared to baseline and control group.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Type 2 Other: Extracorporeal low-intensity shockwave Not Applicable

Detailed Description:
Diabetic nephropathy is the major contributor to end stage renal disease worldwide. Extracorporeal shock wave treatments (ESWT) with low-intensity was reported to be beneficial in inducing cell regeneration and reducing inflammation and have been successfully used for bone fracture, cardiac ischemia, and erectile disorders. In this study, sixty patients with stage III & IV (15<=estimated glomerular filtration rate (eGFR)<60 ml/min/1.73m2) will be recruited and allocated to control and experimental groups in a 1:1 ratio. In experiment group, a total of 1200 shockwaves, with low energy density 0.1mj/mm2 and a frequency of 120 shocks/min, will be applied per kidney per treatment session. The treatment will be given twice a week for 3 consecutive weeks, followed by 3 weeks of recess and an additional series of 6 sessions (totally 12 times). Patients in each group will be evaluated with eGFR, urine protein-creatinine ration, blood pressure, and biochemistry data at the beginning (index day) and 12 months after starting of the therapy. (Outcome time point: 12 months)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigation on the Effects of Extracorporeal Low-intensity Shockwave Therapy on Protenuria, Renal Function, and Blood Pressure in Type 2 Diabetic Patients in Stage 3-4 Chronic Kidney Disease
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sham Comparator: Control
No intervention, no placebo, but do the same blood tests and examinations as experiment group at the same time points
Other: Extracorporeal low-intensity shockwave
Omnispec device to give a total of 1200 shockwaves, with low energy density at 0.1 mj/mm2 and a frequency of 120 shocks/min per kidney per treatment session, totally 12 times.

Experimental: Extracorporeal low-intensity shockwave group
with 12 times extracorporeal low intensity shockwave therapy and do the blood test and assessments at baseline, 3, 6, 12 m after initiation of therapy.
Other: Extracorporeal low-intensity shockwave
Omnispec device to give a total of 1200 shockwaves, with low energy density at 0.1 mj/mm2 and a frequency of 120 shocks/min per kidney per treatment session, totally 12 times.

Primary Outcome Measures :
  1. changes of estimated glomerular filtration rate [ Time Frame: 12 month ]
    using Modification of Diet in Renal Disease (MDRD) equation, which is eGFR (mL/min/1.73m2) = 175 × serum creatinine−1.154 × age−0.203× 0.742 (if female) to evaluate renal function

  2. changes of proteinuria [ Time Frame: 12 month ]
    using spot urine albumin- and protein-creatinine ratio

Secondary Outcome Measures :
  1. changes of systolic and diastolic blood pressure [ Time Frame: 12 month ]
    Let patients rest for 15 mins and check blood pressure using same sphygmomanometer.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age >18 y/o or <80 y/o
  2. Diagnosed as type 2 diabetes.
  3. Baseline HbA1C <7.5%
  4. Baseline glomerular filtration rate (eGFR) ≧15 and <60 ml/min/1.73m2
  5. Baseline urine albumin-to-creatinine ratio (UACR) >30 and <3000 mg/g
  6. Subject receives ACEi or ARB for 3 months before enrollment
  7. Subject is willing to sign the permit and receive 12 times shockwave therapy

Exclusion Criteria:

  1. Subject is pregnant or breast feeding
  2. Subject has cancer or chronic inflammatory disease
  3. Subject has bleeding tendency, eg thrombocytopenia, PT INR > 2.5
  4. Subject has active urinary tract infection or other active infections
  5. Subject's sBP>160mmHg or dBP>100mmHg
  6. Subject has stroke, cardiac infection or arrhythmia in 6 months before enrollment
  7. Subject has local inflammation or infection over treatment areas
  8. Subject has pacemaker or other metal implants.

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 identifier (NCT number): NCT03445247

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Contact: Lung-Chih Li, MD, PhD. 886-7-7317123 ext 8306

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Kaohsiung Chang-Gung Memorial Hospital Recruiting
Kaohsiung, Please Select, Taiwan, 833
Contact: Lung-Chih Li, MD.PhD    886-7317123 ext 8306   
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital Identifier: NCT03445247    
Other Study ID Numbers: 104-7771A
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Diabetic Nephropathies
Extracorporeal low intensity shockwave therapy
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases