Differential Regulation of miRNA and Protein in Human Plasma Extracellular Vesicles by Different Types of Exercise.

The Relationship Between Exercise-drived Exosomes and Diabetes Mellitus.

Aims/hypothesis: Both continuous aerobic training (CAT) and high intensity interval training (HIIT) are recommended to promote health and prevent diseases. Exercise-induced circulating extracellular vesicles (EX-EVs) have been suggested to play essential roles in mediating organ crosstalk, but corresponding molecular mechanisms remain largely unexplored. We aimed to assess and compare the systemic effects of CAT and HIIT via multi-omics integration analysis of EX-EVs.

Methods: Five healthy male volunteers were assigned to HIIT (20 minutes of cycling with periods of 2 minutes at 80-95% HRmax separated by 2 minutes of active recovery) and CAT (20 minutes of cycling at 60-80% of HRmax), with a 7-day interval between sessions. Plasma EVs were collected at rest or immediately after each training section, prior to proteomics and miRNA profile analysis.

Study Overview

• Status: Completed
• Conditions: Diabetes; Exercise; Lifestyle Intervention
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

Before the formal experiment, the volunteers were undergoing a thorough physical examination and proper training to ensure that they were able to complete the experiment. The participants refrained from exercise 24 hours prior to the test to ensure the integrity and accuracy of the results. All volunteers had a standardized breakfast, and all tests started at 9:00 a.m. The volunteers successively completed both HIIT and CAT under the supervision of a professional coach, and the interval between each type of exercise was 7 days. Each training session was initiated with a brief 2-minute standardized warm-up, followed by 20 minutes of cycling consisting of periods of 2 minutes at 80-95% maximal heart rate (HRmax) separated by 2 minutes of active recovery for the HIIT group or 20 minutes of cycling at 60-80% of HRmax for the CAT group. A real-time heart rate monitoring system was continuously used during each training session. The participants were instructed to continue their regular physical activities and eating habits throughout the intervention period. Blood samples were collected at rest or immediately after each training session for further analysis.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Department of Endocrinology and Metabolism, Research Center for Islet Transplantation, West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

18-65 years of age Body mass index (BMI) values between 18-28 kg/m2 More than 3 h of physical activity per week Acknowledgment of informed consent.

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Exclusion Criteria:

Smokers Body weight change >5 kg in 6 months Unsuitable for physical training (heart disease, respiratory disorders or any conditions that could be aggravated by exercise) Currently taking medication or having a history of medication such as steroids, beta-blockers or anticoagulants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: exercise training group; All volunteers had a standardized breakfast, and all tests started at 9:00 a.m. The volunteers successively completed both high intensity interval training (HIIT) and continuous aerobic training (CAT) under the supervision of a professional coach, and the interval between each type of exercise was 7 days. Each training session was initiated with a brief 2-minute standardized warm-up, followed by 20 minutes of cycling consisting of periods of 2 minutes at 80-95% maximal heart rate (HRmax) separated by 2 minutes of active recovery for the HIIT group or 20 minutes of cycling at 60-80% of HRmax for the CAT group. A real-time heart rate monitoring system was continuously used during each training session.

Behavioral: Exercise; The volunteers successively completed both high intensity interval training (HIIT)and continuous aerobic training (CAT) under the supervision of a professional coach, and the interval between each type of exercise was 7 days. Each training session was initiated with a brief 2-minute standardized warm-up, followed by 20 minutes of cycling consisting of periods of 2 minutes at 80-95% maximal heart rate (HRmax) separated by 2 minutes of active recovery for the HIIT group or 20 minutes of cycling at 60-80% of HRmax for the CAT group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
miRNA and proteins in human plasma-derived extracellular vesicles	Measuring miRNA and proteins in human plasma-derived extracellular vesicles through high-throughput sequencing	From enrollment to the end of intervention at 2 weeks

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Per-Olof Berggren, Department of Molecular Medicine and Surgery, Karolinska Institutet, SE-17177 Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: Beginning 1 year and ending 3 years after publication
• IPD Sharing Access Criteria: Any researchers who has undergone an approval process will be able to access the IPD and supporting information, Applicants are required to submit a data use application via the following email( yrou2001@163.com ),including the research plan and other relevant documents. Once approved , the applicant will receive the data via a secure file transfer method.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No