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Training Induced Muscle Exosome Release (TIMER)

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. Identifier: NCT04500769
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
John McCarthy, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Metabolism Behavioral: Acute Resistance Exercise Not Applicable

Detailed Description:
Numerous studies in humans and animals have shown that aerobic exercise is beneficial to adipose tissue function and whole-body metabolism. Both acute and chronic aerobic exercise enhance adipocyte catecholamine sensitivity in humans and animals. Although relatively few studies have investigated whether adipose adrenergic signaling is affected by resistance exercise (RE), it is known that a single bout of RE can increase circulating NEFA and resting energy expenditure and decrease respiratory quotient for up to 24 hours, indicative of increased adipocyte lipolysis and muscle fatty acid oxidation. Furthermore, the lipolytic response to RE is impaired in obese men. Using synergist ablation, a model of RE in mice, the investigators show that adipose transcriptional responses are exosome-dependent, and that serum exosomes enhance adipocyte catecholamine sensitivity and lipolysis for at least 24 hours. To the investigator's knowledge, this is the first demonstration of a potential mechanism whereby RE imparts metabolic adaptations in adipose. Since adipose metabolic function is crucial for determining whole-body metabolic outcomes, the ability of RE-induced exosomes to improve adipose metabolism has significant clinical implications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise-induced Skeletal Muscle Exosomes Promote Adipocyte Lipolysis
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acute Resistance Exercise
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
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).
Other Name: Strength Training

Primary Outcome Measures :
  1. miR-1 abundance [ Time Frame: 90 minutes ]
    Exosomal, muscle, and adipose miR-1 abundance will be quantified at baseline and following an acute bout of resistance exercise by qPCR. Primary miR-1A/B abundance in muscle and adipose will also be quantified by qPCR. Mir-1 and primary miR-1A/B abundance will be normalized to U6 RNA or Rpl38 abundance,respectively, with normalized expression presented in arbitrary units.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18-30 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.

Exclusion Criteria:

  • 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.
  • Any other condition or events considered exclusionary by the PI and/or physician, such as non-compliance.
  • Lidocaine allergy (1% lidocaine is the local anesthetic used during the muscle biopsy procedure).
  • Pregnancy.

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 identifier (NCT number): NCT04500769

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Contact: Douglas Long, M.S. 859-323-5438
Contact: John McCarthy, Ph.D. 859-323-4730

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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Douglas Long, M.S.    859-323-5438   
Contact: John McCarthy, Ph.D.    859-323-4730   
Principal Investigator: Charlotte Peterson, Ph.D.         
Sub-Investigator: Philip Kern, M.D.         
Sponsors and Collaborators
John McCarthy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: John McCarthy, Ph.D. University of Kentucky
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Responsible Party: John McCarthy, Associate Professor, Principal Investigator, University of Kentucky Identifier: NCT04500769    
Other Study ID Numbers: 43910
3R01DK119619-02S1 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John McCarthy, University of Kentucky:
Extracellular Vesicles
Resistance Exercise