A Pilot Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)
研究概览
简要总结
This study will evaluate if Ursolic Acid supplementation may be effective in reducing muscle loss and improving blood sugar control in the SCI community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Male and female individuals with paraplegia having chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from T2-T8
- •Male and female individuals wi4.th chronic (> 1 year) motor-complete and incomplete (AIS A/B/C) injuries from C4-C7
排除标准
- •Pregnant or planning to become pregnant
- •Women who are breastfeeding
研究组 & 干预措施
UA and exercise in paraplegia group
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
干预措施: Ursolic Acid (Drug)
UA and exercise in paraplegia group
Participants will take UA 4 capsules twice daily for 12 weeks while participating in an exercise program, 3 times per week.
干预措施: Strength Training (Other)
UA in tetraplegia group
Participants will take UA 4 capsules twice daily for 12 weeks
干预措施: Ursolic Acid (Drug)
结局指标
主要结局
Change in Muscle Mass Using Dual X-ray Absorptiometry (DXA)
时间窗: Baseline, 12 weeks
Changes in muscle mass in grams as measured by Dual X-ray Absorptiometry
Changes in Peak Isokinetic Strength
时间窗: Baseline, 12 weeks
Peak strength (peak torque in ft-lb) of both arms at 90 degrees range of motion will be tested in elbow flexion and extension (at 60 deg/s) on a Biodex dynamometer
Changes in Fasting Insulin Resistance (IR)
时间窗: Baseline, 12 weeks
Changes in IR using Homeostatic Model of Assessment (HOMA) v2 model estimates steady state beta cell function and insulin sensitivity as percentages of a normal reference population. The change in resting IR will be measured by (fasting serum glucose\*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity.
Changes in Glucose Disposal
时间窗: Baseline, 12 weeks
Changes in glucose disposal will be measured by the Oral Glucose Tolerance Test (OGTT) using Trutol glucose solution of 75 grams. The rates of glucose disposal will be defined by the area under the glucose challenge curve (AUC).
次要结局
未报告次要终点
研究者
Mark S. Nash, Ph.D., FACSM
Professor
University of Miami