Postprandial Lipid Tracer and Exercise in Spinal Cord Injury

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Kevin Allen Jacobs，University of Miami

Tracking Information

First Submitted Date ^ICMJE

June 25, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

May 30, 2018

Estimated Primary Completion Date

March 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.
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.
Concentration of sugar in the blood[ Time Frame: 460 minutes ]
Concentration of glucose in the blood before and after a test meal.
Concentration of hormones in the blood[ Time Frame: 460 minutes ]
Concentration of insulin and catecholamines in the blood before and after a test meal.
Markers of systemic inflammation[ Time Frame: Baseline ]
Concentration of high-sensitivity C-reactive protein (hs-CRP) in the blood

Descriptive Information

Brief Title ^ICMJE

Postprandial Lipid Tracer and Exercise in Spinal Cord Injury

Official Title ^ICMJE

Postprandial Fat Metabolism Following an Acute Exercise Bout in Persons With Spinal Cord Injuries

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

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: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Seated control (CON)
Seated rest
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).

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2020

Estimated Primary Completion Date

March 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Males and females 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. - Pregnancy determined by urine testing in sexually active females. - Imprisonment in state or federal jail or prison.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Kevin Allen Jacobs，University of Miami

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Kevin A Jacobs, PhD University of Miami

PRS Account

University of Miami

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名