NCT06882460招募中不适用
Lifestyle Solutions to Postprandial Hypotension in Spinal Cord Injury
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Magnitude of systolic blood pressure decrease (in-lab)
研究概览
简要总结
The purpose of this study is to determine if a low glycemic diet and lower-body electrical stimulation can reduce postprandial hypotension in individuals with chronic spinal cord injury.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury (SCI) between C4 and T12 who require use of wheelchair for daily mobility
- •AIS A or B
- •>1-year post-injury
排除标准
- •Currently pregnant of breast-feeding
- •Type 1 or 2 diabetes
- •Previous gut augmentation bariatric surgery
- •Neurological impairment other than SCI
- •History of uncontrolled autonomic dysreflexia
- •History of bone fractures
- •Use of abdominal binder or anti-hypotensive drugs
- •Fitted with pacemaker or defibrillator
- •Currently receiving electrical stimulation training or in the previous year
研究组 & 干预措施
High glycemic load
Placebo Comparator
干预措施: High glycemic load diet (Other)
Low glycemic load
Experimental
干预措施: Low glycemic load (Other)
Electrical Stimulation
Experimental
干预措施: Electrical stimulation exercise (Other)
Electrical Stimulation
Experimental
干预措施: High glycemic load diet (Other)
结局指标
主要结局
Magnitude of systolic blood pressure decrease (in-lab)
时间窗: Visit 2-4, Day 1
Calculated as the maximum decrease in systolic blood pressure in the 2-h after eating breakfast and lunch under laboratory-controlled conditions
次要结局
- Postprandial glucose (in-lab)(Visits 2-4, Day 1)
- Magnitude of systolic blood pressure decrease (at-home)(Visits 2-4, Days 1-3)
- Postprandial insulin (in-lab)(Visits 2-4, Day 1)
- Postprandial glucose (at-home)(Visits 2-4, Day 1-3)
- Blood flow (in-lab)(Visits 2-4, Day 1)
研究者
Ceren Yarar-Fisher
Principal Investigator
The Craig H. Neilsen Foundation
研究点 (1)
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