NCT04500769

Brief Summary

The primary objective of this study is to quantify miR-1 release from muscle in extra-cellular vesicles following an acute resistance exercise bout and potential delivery to subcutaneous adipose tissue in young healthy and obese adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 17, 2024

Completed
Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

3.7 years

First QC Date

July 29, 2020

Results QC Date

November 27, 2023

Last Update Submit

December 19, 2025

Conditions

Metabolism

Keywords

MetabolismMuscleExtracellular VesiclesExosomesResistance Exercise

Outcome Measures

Primary Outcomes (1)

  • miR-1 Abundance

    Exosomal, muscle, and adipose miR-1 abundance will be quantified at baseline and following an acute bout of resistance exercise by qPCR.

    90 minutes

Study Arms (1)

Acute Resistance Exercise

EXPERIMENTAL

Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM determined during a previous visit.

Behavioral: Acute Resistance Exercise

Interventions

Acute Resistance ExerciseBEHAVIORAL

Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).

Also known as: Strength Training
Acute Resistance Exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age.
  • Either BMI \<25 or \>30.
  • Relatively sedentary, reporting no participation in regular (\>1 day per week) exercise for at least the past 3 months.
  • Non-smoker.

You may not qualify if:

  • BMI between 25 and 30.
  • Evidence or signs and symptoms for cardiovascular disease (previous heart attack, arrhythmias, angina, shortness of breath, extreme fatigue, unusual pain in neck, jaw, throat, upper abdomen, or back, swelling in feet, legs, or ankles).
  • Evidence or signs and symptoms of metabolic syndrome or disorder (diagnosis of diabetes or insulin resistance, elevated BP, high fasting blood sugar, abnormal cholesterol or triglyceride levels).
  • Chronic aspirin or NSAID use (unless it can be safely stopped prior to the biopsies), and any other use of an anticoagulant (e.g., Coumadin) or history of bleeding including history of hypo- or hyper-coagulation disorders.
  • Neurological, musculoskeletal, or other disorder that would preclude safe participation in the weight lifting tasks and all performance tests.
  • Any other medical condition that would interfere with testing or increase one's risk of complications during exercise, as judged by the study physician.
  • Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Douglas Long
Organization
University of Kentucky
delong2@uky.edu
859-323-5438

Study Officials

  • John McCarthy, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Yuan Wen, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 5, 2020

Study Start

March 14, 2019

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

January 14, 2026

Results First Posted

January 17, 2024

Record last verified: 2025-12

Locations

US(1)