Clinical trial NCT03691532: Postprandial Lipid Tracer and Exercise in Spinal Cord Injury
Official title: Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: lipemia
feeding
paraplegia
tetraplegia
physical activity
macronutrient metabolism
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2018-10-01
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Mixed-crossover: three separate groups (paraplegia, tetraplegia, and neurologically intact) undergo two conditions (seated control and exercise) in a randomized order.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Males 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.
* Imprisonment in state or federal jail or prison.

Primary outcomes:
measure: Rates of postprandial exogenous vs. endogenous fat use
timeFrame: 400 minutes
Secondary outcomes:
measure: Contribution of exogenous fat to postprandial changes in plasma triglycerides
timeFrame: 400 minutes
measure: Concentration of fats in the blood
timeFrame: 460 minutes
measure: Concentration of sugar in the blood
timeFrame: 460 minutes
measure: Concentration of hormones in the blood
timeFrame: 460 minutes
measure: Markers of systemic inflammation
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: Lois Pope Life Center
state: Florida
Study officials:
affiliation: University of Miami
name: Kevin A Jacobs, PhD
role: PRINCIPAL_INVESTIGATOR
References: