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Hyperbaric Oxygen Therapy for Renal Regeneration in Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT03376282
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Shay Efrati, Assaf-Harofeh Medical Center

Brief Summary:

Diabetes kidney disease is a leading cause for end stage renal disease in the western world. To date no treatment that can reverse renal damage exists.

Chronic hypoxia is one of the major key insults affecting the diabetic kidney, and many of the new treatments under study focus on it's consequences, but no treatment can improve the hypoxia as both increased renal perfusion and decreased renal perfusion may be associated with it's worsening. Hyperbaric oxygen therapy (HBOT) can improve renal hypoxia by increasing partial pressure of dissolved (non-hemoglobin-bound) oxygen without affecting it's demand. HBOT also recruits tissue and peripheral progenitors and supplies the optimal environment crucial for their proliferation and for tissue repair. Hyperbaric oxygen treatment was known for years as an effective treatment for diabetic ulcers. Recent trials have shown great impact on brain lesions (in diabetic and non-diabetic patients) it is now the time to evaluate the effect of HBOT on the diabetic kidney.


Condition or disease Intervention/treatment Phase
Chronic Renal Failure Other: Hyperbaric Oxygen oxygen therapy (HBOT) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Hyperbaric Oxygen Therapy on Kidney Function, Perfusion, Fibrosis and Proteinuria in Diabetic Patients With Diabetic Kidney Disease
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
HBOT treatment
HBOT treatment: 60 daily sessions, 5 days/week, 120 minutes each, 100% oxygen at 2ATA.
Other: Hyperbaric Oxygen oxygen therapy (HBOT)
60 daily sessions, 5 days/week, 120 minutes each, 100% oxygen at 2ATA.

No Intervention: Standard treatment
follow up with the standard recommended treatment



Primary Outcome Measures :
  1. glomerular filtration rate [ Time Frame: within a month after treatment ]
  2. proteinuria [ Time Frame: within a month after treatment ]

Secondary Outcome Measures :
  1. renal blood flow (BOLD) [ Time Frame: within a month after treatment ]
  2. fibrosis (DWI MRI) [ Time Frame: within a month after treatment ]


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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
Criteria

Inclusion Criteria:

  • The participants are patients of age 18 years or older, who suffered DKD, defined as eGFR<60ml/min as estimated using MDRD formula, and albuminuria in the presence of diabetes. Diabetic retinopathy and without any alternative cause for their renal disease.

Exclusion Criteria:

  • Exclusions criteria are chest pathology incompatible with HBOT, inner ear disease, claustrophobia. Smoking is not allowed during the study. Patients with uncontrolled diabetes HBA1C>7.5, recent AKI (3M) recent cardiovascular or cerebrovascular event (6M) or inability to hold the breath for 20-30 seconds are also excluded.

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 ClinicalTrials.gov identifier (NCT number): NCT03376282


Contacts
Contact: Keren Doenyas, MD 972-544215487 kerendoenyas@gmail.com
Contact: Smadar Dadush 97289779383

Locations
Israel
Dialysis Clinic in Asaf Harofhe Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Keren Doenyas, MD    972544215487    kerendoenyas@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Keren Doenyas, MD Asaf-Harofhe MC

Responsible Party: Prof. Shay Efrati, Head of HyperBaric center assaf-Harofhe MC, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03376282     History of Changes
Other Study ID Numbers: 84-15
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Shay Efrati, Assaf-Harofeh Medical Center:
HBO
kidney functions
markers

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic