Oxygen Therapy in Diabetic Kidney Disease
April 28, 2025 updated by: Hodna Abdullah Ahmed, Assiut University
Oxygen Therapy in Diabetic Kidney Disease and Its Effect on Proteinuria and Blood Glucose Level
Diabetic kidney disease (DKD) is the most significant cause of end-stage kidney disease (ESKD).
Albuminuria, evolving from microalbuminuria to nephrotic-range proteinuria, is a clinical hallmark of diabetic nephropathy (DN).
It develops in about a third of diabetic patients and is considered an independent risk factor in the progression of DN and for all-cause mortality.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
According to the International Diabetes Federation's report, over 530 million people worldwide have diabetes . About one-third of diabetic patients develop diabetic nephropathy (DN) after the incubation period, which may last several years.
Diabetic kidney disease (DKD) is the most significant cause of end-stage kidney disease (ESKD). Albuminuria, evolving from microalbuminuria to nephrotic-range proteinuria, is a clinical hallmark of diabetic nephropathy (DN). It develops in about a third of diabetic patients and is considered an independent risk factor in the progression of DN and for all-cause mortality.
The management of diabetes includes lifestyle modifications, pharmacological interventions, and emerging therapies such as hyperbaric oxygen therapy (HBOT). It involves exposing patients to high levels of oxygen in a pressurized chamber, leading to various physiological effects .
HBOT increases the level of oxygen in tissues by complete saturation of haemoglobin and increasing the partial pressure of oxygen dissolved in plasma. This enables oxygen to diffuse into tissues compromised by acute inflammation and microvascular disease and dysfunction.
Study Type
Interventional
Enrollment (Estimated)
80
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
- Name: Hodna Abdullah Ahmed, MSC
- Phone Number: +201009468368
- Email: hodnaabdullah@med.aun.edu.eg
Study Contact Backup
- Name: Ashraf Anwar Thabet, professor
- Phone Number: +201062879221
- Email: ashrafshazly@aun.edu.eg
Study Locations
-
-
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Assiut, Egypt
- Assuit university hospitals
-
Contact:
- Mohamed Faisal Adawy, Lecturer
- Phone Number: +201001244126
- Email: DR-m.faisal85m@aun.edu.eg
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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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diabetic male and female patients aged > 18 yrs with diabetic kidney disease (eGFR 30-90 mL/min/1.73m² and proteinuria >300 mg/day)
Exclusion Criteria:
- Age < 18 yrs
- Cardiovascular disease (thorough assessment of the patient's medical history (symptoms suggestive of CVD (e.g., chest pain, shortness of breath, fatigue), family history of CVD and risk factors (e.g., hypertension, hyperlipidemia, smoking). Physical Examination including blood pressure measurement, auscultation of heart sounds and assessment of peripheral pulses. Additional Diagnostic Tests: Stress test (stress ECG and stress echocardiography): Evaluate cardiac function under stress, which can help detect coronary artery disease or other CVD.
- Chronic lung disease (COPD, pulmonary fibrosis …
- Other chronic disease affecting kidney function (lupus nephritis).
- Pregnancy or lactation.
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 |
|---|---|
|
Active Comparator: Group A
About 20 patients suffering from Diabetic kidney disease and will be treated by exposing to early morning air for 60 minutes (Early morning air" refers to the fresh, cool air found during the early hours of the day, (it's around 5-7 am, just before or after sunrise).
|
Other Names:
|
|
Active Comparator: Group B
About 20 patients suffering from Diabetic kidney disease and will be treated by exposing to oxygen by non- rebreather mask (We choose oxygen by non- rebreather mask and no other ways of oxygen delivery system because it is the only available cost effective and non-invasive oxygen delivery device that can provide high oxygen flow that is close enough to HBOT)
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Other Names:
|
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Active Comparator: Group C
About 20 patients suffering from Diabetic kidney disease and will be treated by exposing to hyperbaric oxygen therapy in a hyperbaric chamber at 2.5 ATA (atmospheres absolute) for 60 minutes per session (we choose 2.5 ATA hyperbaric oxygen therapy in a hyperbaric chamber (atmospheres absolute) for 60 minutes per session.
|
Other Names:
|
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Active Comparator: Group D
About 20 patients suffering from Diabetic kidney disease and will receive standard diabetes and Diabetic kidney disease management
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improving of proteinuria in diabetic kidney disease
Time Frame: 6 months
|
to estimate urinary albumin-to-creatinine ratio in patients suffering form diabetic kidney disease
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ashraf Anwar Thabet, Professor, Assiut University
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 (Estimated)
August 1, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 10, 2026
Study Registration Dates
First Submitted
April 28, 2025
First Submitted That Met QC Criteria
April 28, 2025
First Posted (Estimated)
May 6, 2025
Study Record Updates
Last Update Posted (Estimated)
May 6, 2025
Last Update Submitted That Met QC Criteria
April 28, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Oxygen Therapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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