Effects of Acute Intermittent Hypoxia (AIH) on Metabolism and Dysglycemia, in Overweight/Obese Persons With Spinal Cord Injuries (SCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
研究概览
简要总结
The purpose of this research is to examine changes in blood glucose control and metabolism in individuals with SCI and non injured controls at rest and during exercise after five days of exposure to IH. This response will be compared with breathing normal room air (a SHAM control).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lower extremity weakness or paralysis at C5 or below resulting from spinal cord injury for at least one year.
- •ASIA Classification A-D Overweight or obese as classified by a Body Mass Index (BMI) (kg/m2) of ≥ 25.0 (CON) and ≥ 22.0 (SCI).
- •SCI and non injured control:
- •Resting SaO2 ≥ 95%
排除标准
- •(SCI and non injured control):
- •Currently hospitalized
- •Resting heart rate ≥120 BPM
- •Resting systolic blood pressure >180 mm Hg
- •Resting diastolic Blood Pressure >100 mmHg
- •Self-reported history of unstable angina or myocardial infarction within the previous month
- •Previous cardiac surgery or condition that evidences ischemic heart disease
- •Cardiopulmonary complication such as COPD
- •Pregnancy determined by urine testing in sexually active females.
研究组 & 干预措施
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM
This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
干预措施: Intermittent Hypoxia (IH) (Device)
Spinal Cord Injury (SCI) Intermittent Hypoxia then SHAM
This arm of individuals with SCI will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
干预措施: SHAM (Device)
Control (CON) Intermittent Hypoxia then SHAM
This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
干预措施: Intermittent Hypoxia (IH) (Device)
Control (CON) Intermittent Hypoxia then SHAM
This arm of non injured control subjects will receive Intermittent Hypoxia (IH) and following a 3 week washout, SHAM treatment interventions.
干预措施: SHAM (Device)
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
干预措施: Intermittent Hypoxia (IH) (Device)
Spinal Cord Injury (SCI) SHAM then Intermittent Hypoxia
This arm of individuals with SCI will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
干预措施: SHAM (Device)
Control (CON) SHAM then Intermittent Hypoxia
This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
干预措施: Intermittent Hypoxia (IH) (Device)
Control (CON) SHAM then Intermittent Hypoxia
This arm of non injured control subjects will receive SHAM and following a 3 week washout, Intermittent Hypoxia (IH) treatment interventions.
干预措施: SHAM (Device)
结局指标
主要结局
Change in Cardioendocrine Risk by Surrogate Blood Measures of the Homeostasis Model Assessment - Insulin Resistance (HOMA 2-IR)
时间窗: Baseline, day 5
Insulin resistance was estimated by the Homeostasis Model Assessment of Insulin Resistance (HOMA2-IR), which is based on fasting glucose and insulin measurements. Values of \> 1.8 were considered insulin resistant.
次要结局
- Change in Exercise Substrate Partitioning as Measured Via VO2 Peak Test(Baseline, day 5)
研究者
Mark S. Nash, Ph.D., FACSM
Professor
University of Miami