Hyperbaric Oxygen Therapy for Renal Regeneration in Diabetic Nephropathy
|ClinicalTrials.gov Identifier: NCT03376282|
Recruitment Status : Unknown
Verified December 2017 by Prof. Shay Efrati, Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- glomerular filtration rate [ Time Frame: within a month after treatment ]
- proteinuria [ Time Frame: within a month after treatment ]
- renal blood flow (BOLD) [ Time Frame: within a month after treatment ]
- fibrosis (DWI MRI) [ Time Frame: within a month after treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376282
|Contact: Keren Doenyas, MDfirstname.lastname@example.org|
|Contact: Smadar Dadush||97289779383|
|Dialysis Clinic in Asaf Harofhe Medical Center||Recruiting|
|Zerifin, Israel, 70300|
|Contact: Keren Doenyas, MD 972544215487 email@example.com|
|Principal Investigator:||Keren Doenyas, MD||Asaf-Harofhe MC|