The Effect of Hyperbaric Oxygen Therapy on Kidney Function, Perfusion, Fibrosis and Proteinuria in Diabetic Patients With Diabetic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- proteinuria
研究概览
简要总结
Diabetes kidney disease is a leading cause for end stage renal disease in the western world. To date no treatment that can reverse renal damage exists.
Chronic hypoxia is one of the major key insults affecting the diabetic kidney, and many of the new treatments under study focus on it's consequences, but no treatment can improve the hypoxia as both increased renal perfusion and decreased renal perfusion may be associated with it's worsening. Hyperbaric oxygen therapy (HBOT) can improve renal hypoxia by increasing partial pressure of dissolved (non-hemoglobin-bound) oxygen without affecting it's demand. HBOT also recruits tissue and peripheral progenitors and supplies the optimal environment crucial for their proliferation and for tissue repair. Hyperbaric oxygen treatment was known for years as an effective treatment for diabetic ulcers. Recent trials have shown great impact on brain lesions (in diabetic and non-diabetic patients) it is now the time to evaluate the effect of HBOT on the diabetic kidney.
详细描述
Scientific background
Diabetic Kidney Disease (DKD):
The kidneys, which are an important target for diabetic induced damage, contribute a lot to this burden. Diabetic nephropathy (DN) is the most common cause of end-stage kidney disease worldwide, associated with increased morbidity and mortality in patients with diabetes.
The pathogenesis of DKD is relatively established, less progress however have been achieved in the effort to heal the diabetic kidney. Current therapies aimed to control blood glucose levels and blood pressure, and in particular, inhibition of the RAS in order to prevent the development of albuminuria and progression of DKD. Many new therapies emerging recently have offered some potential, but yet none of them had proven effect on the renal progression.
While TGF beta1, MAPK, HIF, VEGF and others have stand in the focus of trials, and drugs that control each of these mediators were offered as the drug that will "make the change" these mediators are probably not the key insult.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants are patients of age 18 years or older, who suffered DKD, defined as eGFR<60ml/min as estimated using MDRD formula, and albuminuria in the presence of diabetes. Diabetic retinopathy and without any alternative cause for their renal disease.
排除标准
- •Exclusions criteria are chest pathology incompatible with HBOT, inner ear disease, claustrophobia. Smoking is not allowed during the study. Patients with uncontrolled diabetes HBA1C>7.5, recent AKI (3M) recent cardiovascular or cerebrovascular event (6M) or inability to hold the breath for 20-30 seconds are also excluded.
研究组 & 干预措施
HBOT treatment
HBOT treatment: 60 daily sessions, 5 days/week, 120 minutes each, 100% oxygen at 2ATA.
干预措施: Hyperbaric Oxygen oxygen therapy (HBOT) (Other)
Standard treatment
follow up with the standard recommended treatment
结局指标
主要结局
proteinuria
时间窗: within a month after treatment
glomerular filtration rate
时间窗: within a month after treatment
次要结局
- renal blood flow (BOLD)(within a month after treatment)
- fibrosis (DWI MRI)(within a month after treatment)
研究者
Shay Efrati
Head of HyperBaric center assaf-Harofhe MC
Assaf-Harofeh Medical Center