Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

NCT ID: NCT03445247

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-06-30

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)

Conditions

Diabetic Nephropathy Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

No intervention, no placebo, but do the same blood tests and examinations as experiment group at the same time points

Group Type: SHAM_COMPARATOR

Extracorporeal low-intensity shockwave

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Extracorporeal low-intensity shockwave

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Chang-Gung Memorial Hospital

Kaohsiung City, Please Select, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Lung-Chih Li, MD, PhD.

Role: CONTACT

longee01@gmail.com

886-7-7317123 ext. 8306

Facility Contacts

Lung-Chih Li, MD.PhD

Role: primary

longee01@gmail.com

886-7317123 ext. 8306

References

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.

Reference Type: DERIVED

PMID: 33131308 (View on PubMed)

Other Identifiers

104-7771A

Identifier Type: -

Identifier Source: org_study_id