Clinical trial NCT06609785: Differential Regulation of miRNA and Protein in Human Plasma Extracellular Vesicles by Different Types of Exercise.
Official title: The Relationship Between Exercise-drived Exosomes and Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Exercise
Lifestyle Intervention
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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 \&gt;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.

Primary outcomes:
measure: miRNA and proteins in human plasma-derived extracellular vesicles
timeFrame: From enrollment to the end of intervention at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Endocrinology and Metabolism, Research Center for Islet Transplantation, West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Molecular Medicine and Surgery, Karolinska Institutet, SE-17177 Stockholm, Sweden
name: Per-Olof Berggren
role: PRINCIPAL_INVESTIGATOR
References: