Oxygen Therapy in Diabetic Kidney Disease

Assiut University

Status: Begins enrollment in 2 months

Conditions: Diabetic Kidney Disease

Treatments: Biological: Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06959485

Oxygen Therapy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Group A

Active Comparator group

Description:

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).

Treatment:

Biological: Oxygen Therapy

Group B

Active Comparator group

Description:

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)

Treatment:

Biological: Oxygen Therapy

Group C

Active Comparator group

Description:

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.

Treatment:

Biological: Oxygen Therapy

Group D

Active Comparator group

Description:

About 20 patients suffering from Diabetic kidney disease and will receive standard diabetes and Diabetic kidney disease management

Treatment:

Biological: Oxygen Therapy