Clinical trial NCT06959485: Oxygen Therapy in Diabetic Kidney Disease
Official title: Oxygen Therapy in Diabetic Kidney Disease and Its Effect on Proteinuria and Blood Glucose Level
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Kidney Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Improving of proteinuria in diabetic kidney disease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University hospitals
Study officials:
affiliation: Assiut University
name: Ashraf Anwar Thabet, Professor
role: STUDY_CHAIR
References: