Clinical trial NCT03445247: Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Nephropathy Type 2
Keywords: Diabetic Nephropathies
Extracorporeal low intensity shockwave therapy
Proteinuria
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: changes of estimated glomerular filtration rate
timeFrame: 12 month
measure: changes of proteinuria
timeFrame: 12 month
Secondary outcomes:
measure: changes of systolic and diastolic blood pressure
timeFrame: 12 month
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang-Gung Memorial Hospital
state: Please Select
Study officials:
References:
citation: Klomjit N, Lerman A, Lerman LO. It Comes As a Shock: Kidney Repair Using Shockwave Therapy. Hypertension. 2020 Dec;76(6):1696-1703. doi: 10.1161/HYPERTENSIONAHA.120.14595. Epub 2020 Nov 2.