NCT01472328已完成不适用
Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
German Diabetes Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Skeletal muscle insulin sensitivity
研究概览
简要总结
Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.
详细描述
HBO therapy is applied to improve wound healing in diabetic patients with foot ulcera. However, it might induce oxidative stress as well as improve antioxidative capacity. The effects on insulin sensitivity in humans and will be tested in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 30 years- ≤ 70 years
- •Balanced sex (50: 50)
- •BMI 20- 25 kg/m 2 normal- weight group
- •BMI 35- 39,9 kg/m 2 (Obese typ II)
排除标准
- •Acute illness 2 weeks before start of examination
- •Autoimmune or Immune disorder deseases (Leukozyten < 5000/µl
- •Renal insufficiency (Kreatin > 1,5 mg/dl)
- •Heart disease, condition after heart attack
- •Anemia (Hb <12g/l, contolled before every day of eximination) or blood donations 4weeks before eximinatin.
- •Participation in another trial within the last 2 weeks
- •Pharmacological- immuno therapy (Cortisol, Antihistaminika, ASS)
- •Thyroid disorders
- •Glitazone or Insulin- Therapy
- •Pragnancy, Lactation, Menstruation
- •Smoking cigaretts, Alcohol- and drug abuse
- •Psychiatric disorders
- •Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C
- •Liver disease, which are not caused by non- alcoholic steato- hepatitis
- •Working on night shifts or irregular rhythem of night- day
- •Impaired wound healing or clotting disorders
- •Allergic reaction to local anesthetics
- •Malignant cancer
结局指标
主要结局
Skeletal muscle insulin sensitivity
时间窗: 2 years
Determination of the influence of 2 hours hyperoxygenation on insulin sensitivity redox balance and lipid metabolites of skeletal muscle in patients with T2DM
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Acute Hyperbaric Oxygen Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in T2DType 2-diabetesNCT04219215German Diabetes Center12
已完成
不适用
Hyperbaric Oxygen Treatment Ameliorates Insulin ResistanceObesityType 2 DiabetesNCT01361971University of Adelaide20
已完成
不适用
Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.Type 2 DiabetesObesityNCT02009813University of Adelaide9
已完成
不适用
Insulin Sensitivity During Hyperbaric Oxygen Compared to Hyperbaric AirDiabetes Mellitus, Type IIInsulin ResistanceNCT03138746University of Adelaide25
已完成
1 期
Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of LifeDiabetesDiabetic Foot UlcerNCT02328508Chen-Yu Chen38