acute exercise and metabolic response
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0006106
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1) Healthy men aged 20 to 40 at the time of screening
2) Those with a body weight of 50 kg or more and a body mass index of 18.5 or more and less than 30
3) Those who do not have congenital or chronic diseases that require treatment and do not have pathological symptoms or abnormal findings as a result of medical examination and physical examination.
4) A person who is determined to be suitable as a clinical trial subject as a result of laboratory tests and physical examinations such as serum tests, hematology tests, blood chemistry tests, and urinalysis tests set and conducted according to the characteristics of the drug during the screening test.
5) A person who voluntarily decides to participate and agrees in writing to observe the precautions after hearing detailed explanation of this clinical trial and fully understanding it.
1) Diabetic patients
2) Intense exercise within the last 1 week or moderate or higher exercise within 24 hours
3) People with NYHA class I or higher breathing difficulties
4) Patients with underlying cardiovascular or respiratory disease
5) History of chest pain or fainting
6) Hemoglobin <12 g/dL
7) Patients with active liver disease or those whose AST, ALT exceeds twice the upper limit of the normal range
8) Decreased renal function: eGFR <60 ml per minute/1.73 square meter
9) Systolic blood pressure >150 mmHg or <90 mmHg, or diastolic blood pressure >100 mmHg or <60 mmHg, or those who are taking antihypertensive drugs after diagnosis of hypertension
10) Those whose heart rate is less than 50 beats per minute at rest or who are contraindicated with beta blockers (propranolol)
11) Those who have suffered serious injuries or have undergone surgical procedures within the last 12 weeks, and those who have symptoms suspected of having acute illness (severe infections, severe trauma patients, etc.)
12) A person who participated in an interventional treatment procedure or another interventional clinical trial that administers drugs within 3 months of the test (however, the end of the previous clinical trial is determined as the last dosing date).
13) Positive factors as a result of serological tests (HBs Ag, HCV Ab, HIV Ab)
14) Subjects with a family history of sudden death of unknown cause among immediate family members
15) Smokers or those taking tranquilizers or psychiatric drugs
16) A person who is judged to be inappropriate to participate in the clinical trial at the judgment of the chief investigator and the person in charge of the study (the doctor in charge)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method During acute exercise, maximal oxygen uptake, Respiratory Quotient (RQ), energy expenditure;Changes in myokines, hormones, and metabolic variables before and after acute exercise (blood collection within 5 minutes immediately after exercise) and recovery period (60 minutes): as major assessment parameters, including IL-6, IL-8, vitamin D, clusterin and muscle function-related substances;Correlation with changes in physiological, metabolic, oxidative stress, and hormone concentrations and changes in serum myokines.
- Secondary Outcome Measures
Name Time Method Changes in miRNA profile in plasma exosomes immediately after acute exercise and recovery phase (miRNA next generation sequencing)