Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-08-01
2026-08-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Oxygen Therapy
1. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on proteinuria in patients with diabetic kidney disease.
2. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on glycated haemoglobin in patients with diabetic kidney disease.
3. Comparing the effects of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask), early morning air exposure, and standard care on kidney function
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)
Oxygen Therapy
1. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on proteinuria in patients with diabetic kidney disease.
2. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on glycated haemoglobin in patients with diabetic kidney disease.
3. Comparing the effects of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask), early morning air exposure, and standard care on kidney function
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.
Oxygen Therapy
1. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on proteinuria in patients with diabetic kidney disease.
2. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on glycated haemoglobin in patients with diabetic kidney disease.
3. Comparing the effects of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask), early morning air exposure, and standard care on kidney function
Group D
About 20 patients suffering from Diabetic kidney disease and will receive standard diabetes and Diabetic kidney disease management
Oxygen Therapy
1. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on proteinuria in patients with diabetic kidney disease.
2. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on glycated haemoglobin in patients with diabetic kidney disease.
3. Comparing the effects of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask), early morning air exposure, and standard care on kidney function
Interventions
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Oxygen Therapy
1. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on proteinuria in patients with diabetic kidney disease.
2. To evaluate the effect of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask) and early morning air on glycated haemoglobin in patients with diabetic kidney disease.
3. Comparing the effects of oxygen therapy (hyperbaric oxygen and oxygen by non- rebreather mask), early morning air exposure, and standard care on kidney function
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
10 Years
17 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hodna Abdullah Ahmed
Resident of Internal medicine
Principal Investigators
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Ashraf Anwar Thabet, Professor
Role: STUDY_CHAIR
Assiut University
Locations
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Assuit University hospitals
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Oxygen Therapy
Identifier Type: -
Identifier Source: org_study_id
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