Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

February 22, 2018 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Please Select
      • Kaohsiung, Please Select, Taiwan, 833
        • Recruiting
        • Kaohsiung Chang-Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 month
changes of proteinuria
Time Frame: 12 month
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
Time Frame: 12 month
Let patients rest for 15 mins and check blood pressure using same sphygmomanometer.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-7771A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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