Oxygen Therapy in Diabetic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxygen Therapy.
- Who it may be relevant to
- Registry conditions: Diabetic Kidney Disease. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Oxygen Therapy in Diabetic Kidney Disease and Its Effect on Proteinuria and Blood Glucose Level
Overview
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.
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.
Interventions
- Biological 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 stan
Primary outcome measures
- Improving of proteinuria in diabetic kidney disease [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Assuit University hospitals — Asyut
Identifiers
NCT: NCT06959485 · Oxygen Therapy