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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seated control (CON)
Arm cycle exercise (ACE)
Liquid meal
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring lipemia, feeding, paraplegia, tetraplegia, physical activity, macronutrient metabolism

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts 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.

Sites / Locations

  • Lois Pope Life Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Seated control (CON)

Arm cycle exercise (ACE)

Arm 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.

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

Outcomes

Primary Outcome Measures

Rates of postprandial exogenous vs. endogenous fat use
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

Contribution of exogenous fat to postprandial changes in plasma triglycerides
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
Concentration of triglycerides, non-esterified fatty acids, and glycerol in the blood before and after a test meal.
Concentration of sugar in the blood
Concentration of glucose in the blood before and after a test meal.
Concentration of hormones in the blood
Concentration of insulin and catecholamines in the blood before and after a test meal.
Markers of systemic inflammation
Concentration of high-sensitivity C-reactive protein (hs-CRP) in the blood

Full Information

First Posted
June 25, 2018
Last Updated
August 21, 2023
Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03691532
Brief Title
Postprandial Lipid Tracer and Exercise in Spinal Cord Injury
Acronym
PPLT
Official Title
Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
lipemia, feeding, paraplegia, tetraplegia, physical activity, macronutrient metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seated control (CON)
Arm Type
Experimental
Arm 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.
Arm Title
Arm cycle exercise (ACE)
Arm Type
Experimental
Arm Description
Participants complete continuous arm cycle exercise (ACE) for ~60 min. Following the intervention they are fed a liquid meal.
Intervention Type
Behavioral
Intervention Name(s)
Seated control (CON)
Intervention Description
Seated rest
Intervention Type
Behavioral
Intervention Name(s)
Arm cycle exercise (ACE)
Intervention Description
Arm cycling at a continuous power output
Intervention Type
Behavioral
Intervention Name(s)
Liquid meal
Intervention Description
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 Measure Information:
Title
Rates of postprandial exogenous vs. endogenous fat use
Description
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.
Time Frame
400 minutes
Secondary Outcome Measure Information:
Title
Contribution of exogenous fat to postprandial changes in plasma triglycerides
Description
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.
Time Frame
400 minutes
Title
Concentration of fats in the blood
Description
Concentration of triglycerides, non-esterified fatty acids, and glycerol in the blood before and after a test meal.
Time Frame
460 minutes
Title
Concentration of sugar in the blood
Description
Concentration of glucose in the blood before and after a test meal.
Time Frame
460 minutes
Title
Concentration of hormones in the blood
Description
Concentration of insulin and catecholamines in the blood before and after a test meal.
Time Frame
460 minutes
Title
Markers of systemic inflammation
Description
Concentration of high-sensitivity C-reactive protein (hs-CRP) in the blood
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin A Jacobs, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lois Pope Life Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Postprandial Lipid Tracer and Exercise in Spinal Cord Injury

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