Oxygen Therapy in Diabetic Kidney Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxygen Therapy

    Biological/Vaccine

    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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 1 intervention
Group C: Group CActive comparator 1 intervention
Group D: Group DActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improving of proteinuria in diabetic kidney disease

to estimate urinary albumin-to-creatinine ratio in patients suffering form diabetic kidney disease

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: