Oxygen Therapy in Diabetic Kidney Disease

NCT06959485 | Not Yet Recruiting DMC

• 1 other identifier: Oxygen Therapy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Improving of proteinuria in diabetic kidney disease

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

  6 months

Study Arms (4)

Group A

ACTIVE COMPARATOR

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).

Biological: Oxygen Therapy

Group B

ACTIVE COMPARATOR

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)

Biological: Oxygen Therapy

Group C

ACTIVE COMPARATOR

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.

Biological: Oxygen Therapy

Group D

ACTIVE COMPARATOR

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

Biological: Oxygen Therapy

Interventions

Oxygen Therapy BIOLOGICAL

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

Also known as: Standard diabetes and CKD management

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Diabetic male and female patients aged \> 18 yrs with diabetic kidney disease (eGFR 30-90 mL/min/1.73m² and proteinuria \>300 mg/day)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University hospitals

Asyut, Egypt

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Ashraf Anwar Thabet, Professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Hodna Abdullah Ahmed, MSC

CONTACT

+201009468368; hodnaabdullah@med.aun.edu.eg

Ashraf Anwar Thabet, professor

CONTACT

+201062879221; ashrafshazly@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Internal medicine

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

EG (1)