Hyperbaric Oxygen Therapy for Renal Regeneration in Diabetic Nephropathy

NCT03376282 | Terminated

• 1 other identifier: 0084-15
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Keywords

HBO; kidney functions; markers

Outcome Measures

Primary Outcomes (2)

• glomerular filtration rate

  within a month after treatment

• proteinuria

  within a month after treatment

Secondary Outcomes (2)

• renal blood flow (BOLD)

  within a month after treatment

• fibrosis (DWI MRI)

  within a month after treatment

Study Arms (2)

HBOT treatment

OTHER

HBOT treatment: 60 daily sessions, 5 days/week, 120 minutes each, 100% oxygen at 2ATA.

Other: Hyperbaric Oxygen oxygen therapy (HBOT)

Standard treatment

NO INTERVENTION

follow up with the standard recommended treatment

Interventions

Hyperbaric Oxygen oxygen therapy (HBOT) OTHER

60 daily sessions, 5 days/week, 120 minutes each, 100% oxygen at 2ATA.

HBOT treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Dialysis Clinic in Asaf Harofhe Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Keren Doenyas, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of HyperBaric center assaf-Harofhe MC

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: December 18, 2017
• Study Start: September 1, 2015
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)