Postprandial Lipid Tracer and Exercise in Spinal Cord Injury

赞助:

合作者:

信息的提供 (责任方):

Kevin Allen Jacobs，University of Miami

追踪信息

首次提交日期 ^ICMJE

June 25, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 1, 2018

预计研究开始日期 ^ICMJE

May 30, 2018

预计主要完成日期

March 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Rates of postprandial exogenous vs. endogenous fat use[ Time Frame: 400 minutes ]

Indirect calorimetry data (rates of CO2 production and O2 consumption) will be input into stoichiometric equations to calculate the rate of whole body fat oxidation (grams/minute). Breath carbon-13 carbon dioxide (13CO2) enrichment data combined with the rate CO2 production from indirect calorimetry will allow for the determination of the individual rates of exogenous and endogenous fat use.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Contribution of exogenous fat to postprandial changes in plasma triglycerides[ Time Frame: 400 minutes ]
Carbon-13 palmitate ([U-13C] enrichment data will allow for the determination of the contribution of exogenous fat to the total blood triglyceride concentration. The contribution of endogenous fat to the total blood triglyceride concentration will be calculated by subtracting the exogenous fat contribution from the total blood triglyceride concentration.
Concentration of fats in the blood[ Time Frame: 460 minutes ]
Concentration of triglycerides, non-esterified fatty acids, and glycerol in the blood before and after a test meal.
Concentration of sugar in the blood[ Time Frame: 460 minutes ]
Concentration of glucose in the blood before and after a test meal.
Concentration of hormones in the blood[ Time Frame: 460 minutes ]
Concentration of insulin and catecholamines in the blood before and after a test meal.
Markers of systemic inflammation[ Time Frame: Baseline ]
Concentration of high-sensitivity C-reactive protein (hs-CRP) in the blood

描述性信息

简略标题 ^ICMJE

Postprandial Lipid Tracer and Exercise in Spinal Cord Injury

正式标题 ^ICMJE

Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries

简要概况

This study investigates the effect of upper extremity exercise on postprandial lipemia (PPL) in persons with spinal cord injury (SCI). Participants are measured at rest and fed a standardized meal following seated rest (CON) or arm cycling exercise (ACE). The meal is infused with "stable isotope lipid tracers" that allow for determination of the end fates of the fat in the meal.

详细说明

Spinal cord injury (SCI) results in dysregulation of fat metabolism that increases the risk of morbidity and mortality from cardioendocrine disease. Excessive accumulation of visceral fat after SCI is a serious risk component for cardioendocrine disease and results in part from pronounced hypertriglyceridemia following ingestion of fat-containing meals (i.e., exaggerated postprandial lipemia; PPL). Although exaggerated PPL is well documented in persons with SCI, its etiology is unknown. Specifically, it remains to be determined to what extent exaggerated PPL in those with SCI results from impairments in the use of exogenous (dietary) and/or endogenous (stored) fats. Additionally, it is not known if exercise improves postprandial fat use in a manner that alleviates the exaggerated PPL in this population and reduces the risk of cardioendocrine disease. The objective of the this study is to examine the mechanisms of exaggerated PPL in those with SCI and the effects of an acute pre-meal exercise bout by employing novel stable isotope tracer techniques. In persons without SCI, it is well established that pre-meal exercise lowers PPL in part by improving the use of exogenous and endogenous fats. While muscle atrophy and blunted sublesional sympathetic activity following SCI may hinder fat use, preliminary data indicate that fat use is increased during recovery from exercise in the postabsorptive (fasted) state in this population. Thus, the investigators hypothesize that decreased use of exogenous and endogenous fats contributes to exaggerated PPL in SCI, and that pre-meal exercise will reduce PPL due to increased use of both fat sources.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Crossover Assignment
干预模型描述: Mixed-crossover: three separate groups (paraplegia, tetraplegia, and neurologically intact) undergo two conditions (seated control and exercise) in a randomized order.
盲法: Interventional
盲法描述:
主要目的: Prevention

适用条件 ^ICMJE

干预项目 ^ICMJE

Behavioral: Seated control (CON)
Seated rest
Behavioral: Arm cycle exercise (ACE)
Arm cycling at a continuous power output
Behavioral: Liquid meal
Liquid meal of 0.5 L volume containing 20 kcal/kg fat free mass (FFM) and 5 mg/kg FFM of uniformly 13-carbon labeled palmitate ([U-13C]palmitate) at a macronutrient distribution of 50% carbohydrate, 35% fat, and 15% protein (by kcal).

研究工具

Experimental: Seated control (CON)
Participants remain seated in their habitual wheel chair for ~60 min (duration of exercise performed in other arm). Following the intervention they are fed a liquid meal.
Experimental: Arm cycle exercise (ACE)
Participants complete continuous arm cycle exercise (ACE) for ~60 min. Following the intervention they are fed a liquid meal.

招募信息

招募状态 ^ICMJE

Active, not recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 2020

预计主要完成日期

March 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Males and females aged 18-60 years. - For the spinal cord injury subgroups, the participant's injury will be: - neurologically stable, - American Spinal Injury Association (ASIA) Impairment Scale A-C, - and will have occurred > 1 year from the testing date. Exclusion Criteria: - Existing diagnosis of cardiovascular disease or diabetes. - Contraindication to exercise (ACSM Guideline, 10th edition). - Lower extremity fracture or dislocation within 6 months of participation. - History of head injury or seizures. - Inability to consent. - Restrictions in upper extremity range of motion that would prevent an individual from achieving an unhindered arm cycling motion or moving throughout a range needed to perform resistance maneuvers. - A pressure ulcer at ischial/gluteus, trochanteric, sacral, or heel sites within the last 3 months. - Pregnancy determined by urine testing in sexually active females. - Imprisonment in state or federal jail or prison.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：60 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Kevin Allen Jacobs，University of Miami

研究赞助商 ^ICMJE

University of Miami

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Kevin A Jacobs, PhD University of Miami

PRS 账户

University of Miami

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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