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

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ClinicalTrials.gov Identifier: NCT03691532
Recruitment Status : Suspended (COVID-19 mitigation)
First Posted : October 1, 2018
Last Update Posted : May 31, 2022
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Kevin Allen Jacobs, University of Miami

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Seated control (CON) Behavioral: Arm cycle exercise (ACE) Behavioral: Liquid meal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Mixed-crossover: three separate groups (paraplegia, tetraplegia, and neurologically intact) undergo two conditions (seated control and exercise) in a randomized order.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Seated control (CON)
Seated rest

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).

Experimental: Arm cycle exercise (ACE)
Participants complete continuous arm cycle exercise (ACE) for ~60 min. Following the intervention they are fed a liquid meal.
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Concentration of sugar in the blood [ Time Frame: 460 minutes ]
    Concentration of glucose in the blood before and after a test meal.

  4. Concentration of hormones in the blood [ Time Frame: 460 minutes ]
    Concentration of insulin and catecholamines in the blood before and after a test meal.

  5. Markers of systemic inflammation [ Time Frame: Baseline ]
    Concentration of high-sensitivity C-reactive protein (hs-CRP) in the blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691532


Locations
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United States, Florida
Lois Pope Life Center
Miami, Florida, United States, 33143
Sponsors and Collaborators
University of Miami
The Craig H. Neilsen Foundation
Investigators
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Principal Investigator: Kevin A Jacobs, PhD University of Miami
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Responsible Party: Kevin Allen Jacobs, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03691532    
Other Study ID Numbers: 20180450
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin Allen Jacobs, University of Miami:
lipemia
feeding
paraplegia
tetraplegia
physical activity
macronutrient metabolism
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System