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Postprandial Lipid Tracer and Exercise in Spinal Cord Injury (PPLT)

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University of Miami

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Behavioral: Seated control (CON)
Behavioral: Arm cycle exercise (ACE)
Behavioral: Liquid meal

Study type

Interventional

Funder types

Other

Identifiers

NCT03691532
20180450

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Seated control (CON)
Experimental group
Description:
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.
Treatment:
Behavioral: Liquid meal
Behavioral: Seated control (CON)
Arm cycle exercise (ACE)
Experimental group
Description:
Participants complete continuous arm cycle exercise (ACE) for \~60 min. Following the intervention they are fed a liquid meal.
Treatment:
Behavioral: Liquid meal
Behavioral: Arm cycle exercise (ACE)

Trial contacts and locations

1

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Central trial contact

Kevin A Jacobs, PhD; David W McMillan, MS

Data sourced from clinicaltrials.gov

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