- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03691532
Postprandial Lipid Tracer and Exercise in Spinal Cord Injury (PPLT)
Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David W McMillan, MS
- Phone Number: 714-300-5832
- Email: dmcmillan@med.miami.edu
Study Contact Backup
- Name: Kevin A Jacobs, PhD
- Phone Number: 305-284-5873
- Email: k.jacobs@miami.edu
Study Locations
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-
Florida
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Miami, Florida, United States, 33143
- Lois Pope Life Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Seated rest
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.
|
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).
Arm cycling at a continuous power output
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
400 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
400 minutes
|
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.
|
460 minutes
|
Concentration of sugar in the blood
Time Frame: 460 minutes
|
Concentration of glucose in the blood before and after a test meal.
|
460 minutes
|
Concentration of hormones in the blood
Time Frame: 460 minutes
|
Concentration of insulin and catecholamines in the blood before and after a test meal.
|
460 minutes
|
Markers of systemic inflammation
Time Frame: Baseline
|
Concentration of high-sensitivity C-reactive protein (hs-CRP) in the blood
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin A Jacobs, PhD, University of Miami
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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