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Trial record 3 of 8 for:    Marco Pahor

Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol (MoTrPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04151199
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Broad Institute
Duke University
Emory University
Icahn School of Medicine at Mount Sinai
Mayo Clinic
Pacific Northwest National Laboratory
University of Michigan
Wake Forest University Health Sciences
Wake Forest University
University of Vermont
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida

Brief Summary:

The goal of the Molecular Transducers of Physical Activity Consortium (MoTrPAC) is to assess molecular changes that occur in response to physical activity (PA). To achieve this aim, studies will be conducted in adults and separately in children and adolescents. The UC Irvine MoTrPAC Pediatric Clinical Center oversees two interrelated study phases in children and adolescents:

  1. A cross-sectional phase in which molecular transducers (obtained from blood sampling) are measured in response to an acute exercise challenge (n = 320);
  2. An intervention phase is conducted as a mechanistic randomized controlled trial (RCT). Participants are recruited from the cross-sectional study phase and randomized to endurance exercise (EE) training (n = 120) or no exercise Control (n = 50) for a period of approximately 12 weeks.

Condition or disease Intervention/treatment Phase
Physical Activity Other: Endurance Training Not Applicable

Detailed Description:

The overarching hypothesis is that there are discoverable molecular transducers that communicate and coordinate the effects of exercise on cells, tissues, and organs, which may initiate processes ultimately leading to the health benefits of exercise. Because this is a mechanistic trial, the main goal is not a health-related outcome. Rather, the goal is to generate a map of the molecular responses to exercise that will be used by the Consortium and by the scientific community at large to generate hypotheses for future investigations of the health benefits of PA. Study assessments are completed before and after the intervention period (exercise or control), and at specific interim time points during the course of the intervention. An additional focus of the pediatric studies is to examine the impact of sex and developmental phase (self-reported pubertal stage) during childhood and adolescence on acute and chronic exercise responses.

Assessments include measurements of cardiorespiratory fitness, muscular strength, and body composition (including whole body bone mineral content) determined by dual-energy x-ray absorptiometry (DXA). There is also collection of blood, monitoring of free-living PA level using wearable devices, and completion of participant reported outcomes and health status by interview and/or questionnaire. As part of the MoTrPAC functions, participant data and biological samples are transferred from the Pediatric Clinical Site to the Consortium Coordinating Center (CCC) Data Management, Analysis and Quality Control Center (DMAQC) and to the Biological Sample Repository, and later analyzed by the Consortium Chemical Analysis Sites (CAS) and the Bioinformatics Center (BIC).

Biological samples collected in this project undergo molecular phenotyping, including metabolomic, lipidomic, proteomic, epigenomic, transcriptomic, and genomic analyses. These assays are done at the MoTrPAC CAS.

Overall coordination of the study and analyses occurs at 4 institutions which make up the CCC and the BIC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Molecular Transducers of Physical Activity Consortium (MoTrPAC) - Pediatric Protocol
Actual Study Start Date : November 22, 2019
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No Intervention Control
The control group does not engage in any exercise during acute testing protocol.
Active Comparator: Endurance Exercise
Participants randomized to ET first engage in a single acute exercise test of Endurance Exerciser (on a cycle ergometer) consistent with their random assignment.
Other: Endurance Training
Participants randomized to EE training engage in three school-based or center-based (PERC) EE training sessions each week for approximately 12 weeks; each session lasting roughly 70 min with a 45-50 minutes of a stimulus phase and the remaining time being used to warm-up and cool down.




Primary Outcome Measures :
  1. Transcriptome in plasma [ Time Frame: Baseline; Week 12 ]
    Changes in mRNA-based expression within blood plasma

  2. Metabolome in plasma [ Time Frame: Baseline; Week 12 ]
    Changes in metabolites within blood plasma

  3. Lipidome in plasma [ Time Frame: Baseline; Week 12 ]
    Changes in lipids within blood plasma

  4. Proteome in plasma [ Time Frame: Baseline; Week 12 ]
    Changes in proteins within blood plasma

  5. Epigenome in plasma [ Time Frame: Baseline; Week 12 ]
    Epigenomic changes within blood plasma

  6. Genomic influence in plasma [ Time Frame: Baseline; Week 12 ]
    Influence of genomic allelic variants on the levels of molecular feature patterns within



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent or legal guardian and participant are willing to provide informed consent and assent to participate in the MoTrPAC Study
  • Must be able to read and speak English well enough to provide informed consent, assent and understand instructions
  • Children and adolescents ages 10-17 (Pubertal stages 1-5)
  • Determined to be in good health by pre-participation medical history review performed at PERC
  • BMI %ile (>5th, <95th)
  • Weight ≥30 Kg (minimum required for blood collection)
  • LAEE children defined as self-reported of no more than 2 days per week, lasting no more than 120 minutes per week, of regular (structured) intense endurance exercise (e.g., running, cycling, elliptical, soccer, swimming and rowing activity that results in feelings of substantially increased heart rate and rapid breathing and sweating with limited ability to talk) in the 3 months prior to study enrollment.
  • HAEE children in this study is defined as:
  • self-reported participation in a structured/regular endurance sports (e.g., running, cycling, soccer, swimming and rowing activity that results in feelings of substantially increased heart rate and rapid breathing and sweating with limited ability to talk).
  • Participation in these activities is ≥4 times per week (>240 min per week) for at least 9 months prior to study enrollment.

Exclusion Criteria:

  • Self-report or laboratory evidence of familial hyperlipidemia/dyslipidemia (e.g., total cholesterol ≥ 200mg/dL and or triglyceride ≥ 100mg/dL)
  • Daily or weekly chronic use of any prescription medication in the past 3 months (excluding birth control)
  • Any use of tobacco, e-cigarettes, illegal drugs, alcohol, or marijuana (self-report) within the last 12 months
  • Pregnancy or breastfeeding
  • Sudden or abrupt (≥5%) weight lost (self-report) over the preceding 3 months
  • Past history of serious chronic diseases (including, but not limited to: asthma, diabetes, juvenile idiopathic arthritis, cystic fibrosis, malignancy, congenital heart disease, cerebral palsy, muscular dystrophy, autoimmune diseases, inflammatory bowel disease)
  • Evidence of disease, disability or other condition that would impair participation in physical activity as determined by a study clinician
  • Blood donation in the past 3 months (self-report)

Similar inclusion/exclusion criteria are being used for the intervention phase, with the additional exclusion criterion of children who meet the definition of HAEE defined above.


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): NCT04151199


Contacts
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Contact: Jane Lu (352) 294-5800 MoTrPAC-ACC@aging.ufl.edu

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Sponsors and Collaborators
University of Florida
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Broad Institute
Duke University
Emory University
Icahn School of Medicine at Mount Sinai
Mayo Clinic
Pacific Northwest National Laboratory
University of Michigan
Wake Forest University Health Sciences
Wake Forest University
University of Vermont
National Institutes of Health (NIH)
Investigators
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Study Director: Marco Pahor, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04151199    
Other Study ID Numbers: MoTrPAC - Pediatric Site
U01AR071158 ( U.S. NIH Grant/Contract )
U24AR071113 ( U.S. NIH Grant/Contract )
U24OD026629 ( U.S. NIH Grant/Contract )
U24DK112349 ( U.S. NIH Grant/Contract )
U24DK112342 ( U.S. NIH Grant/Contract )
U24DK112340 ( U.S. NIH Grant/Contract )
U24DK112341 ( U.S. NIH Grant/Contract )
U24DK112326 ( U.S. NIH Grant/Contract )
U24DK112331 ( U.S. NIH Grant/Contract )
U24DK112348 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
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