NCT06959485

Oxygen Therapy in Diabetic Kidney Disease

Oxygen Therapy in Diabetic Kidney Disease and Its Effect on Proteinuria and Blood Glucose Level

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
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 standard care on kidney function

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-10
• First posted: 2025-05-06
• Last updated: 2025-05-06

Locations

1 site across 1 country: Egypt