Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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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

Conditions
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Diabetic Nephropathy Type 2

Intervention / Treatment
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* Other: Extracorporeal low-intensity shockwave


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 y/o or <80 y/o Diagnosed as type 2 diabetes. Baseline HbA1C <7.5% Baseline glomerular filtration rate (eGFR) ≧15 and <60 ml/min/1.73m2 Baseline urine albumin-to-creatinine ratio (UACR) >30 and <3000 mg/g Subject receives ACEi or ARB for 3 months before enrollment Subject is willing to sign the permit and receive 12 times shockwave therapy Exclusion Criteria: Subject is pregnant or breast feeding Subject has cancer or chronic inflammatory disease Subject has bleeding tendency, eg thrombocytopenia, PT INR > 2.5 Subject has active urinary tract infection or other active infections Subject's sBP>160mmHg or dBP>100mmHg Subject has stroke, cardiac infection or arrhythmia in 6 months before enrollment Subject has local inflammation or infection over treatment areas Subject has pacemaker or other metal implants.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>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<br>* 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.<br>|
| Experimental: Extracorporeal low-intensity shockwave group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of estimated glomerular filtration rate | 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 | 12 month | 
| changes of proteinuria | using spot urine albumin- and protein-creatinine ratio | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of systolic and diastolic blood pressure | Let patients rest for 15 mins and check blood pressure using same sphygmomanometer. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Nephropathies, Extracorporeal low intensity shockwave therapy, Proteinuria