NCT04334343进行中（未招募）不适用
Investigating the Effects of Aerobic and Resistance Training in Vivo on Skeletal Muscle Metabolism in Vitro in Primary Human Muscle Cells (MoTrMyo)
AdventHealth Translational Research Institute2 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2020年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Mitochondrial function
研究概览
简要总结
The goal of the study is to examine the ability of resistance or aerobic exercise training to "imprint" skeletal muscle cells in a manner which confers long-term changes in this tissue which in-turn contribute to improved metabolic health and functional capacity through epigenetic regulation of novel exercise response genes. This study will also provide primary human skeletal muscle cells to the Molecular Transducers of Physical Activity Consortium (MoTrPAC) (NCT03960827) repository for future use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ADULT PARTICIPANT INCLUSION CRITERIA - SEDENTARY PARTICIPANTS
- •Willingness to provide informed consent to participate in the MoTrPAC Study
- •Willingness to undergo an extra needle insertion for the extra muscle tissue collection during the MoTrPAC muscle biopsy
- •Must be able to read and speak English well enough to provide informed consent and understand instructions
- •Aged ≥18 y
- •Body Mass Index (BMI) >19 to <35 kg/m2
- •Sedentary defined as self-reporting no more than 1 day per week, lasting no more than 60 minutes, of regular (structured) EE [e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate, rapid breathing, and/or sweating] or RE (resulting in muscular fatigue) in the past year
- •Persons bicycling as a mode of transportation to and from work >1 day/week etc. are not considered sedentary
- •Leisure walkers are included unless they meet the heart rate, breathing, and sweating criteria noted above
- •ADULT PARTICIPANT INCLUSION CRITERIA - HIGHLY ACTIVE PARTICIPANTS
- •Willingness to provide informed consent to participate in the MoTrPAC Study
- •Willingness to undergo an extra needle insertion for the extra muscle tissue collection during the MoTrPAC muscle biopsy
- •Must be able to read and speak English well enough to provide informed consent and understand instructions
- •Aged ≥18 y
- •BMI >19 to <35 kg/m2
- •Comparator Participants
- •Highly Active Endurance Exercise (HAEE): defined as >240 minutes/week of ET for >1 year; this can include running, walking (brisk, power), cycling, elliptical, etc. which (at a minimum) results in increased heart rate, rapid breathing and sweating
- •Must include cycling at least 2 days/week
- •Highly Active Resistance Exercise (HARE): defined as RT of ≥3 upper and ≥3 lower body muscle groups ≥2 times/week for >1 year; using a prescription sufficient to increase strength and muscle mass
- •Elite or Competitive Athletes: can be included, if they meet HAEE or HARE inclusion criteria
- •Potential participants are informed that use of performance enhancing drugs in the last 6 months is exclusionary
- •In addition to meeting HAEE or HARE inclusion criteria, all HA participants must meet all other
排除标准
- •defined in this protocol
- •Individuals who meet inclusion criteria for both HAEE and HARE are exclude
- •EXCLUSION CRITERIA
- •ADULT PARTICIPANT EXCLUSION CRITERIA Exclusion criteria are confirmed by either self-report (i.e., medical and medication histories reviewed by a clinician), screening tests performed by the MoTrPAC study team at each clinical site, and/or clinician judgement as specified for each criterion.
- •Diabetes (self-report and screening tests)
- •Treatment with any hypoglycemic agents (self-report) or A1c >6.4 (screening test; may reassess once if 6.5-6.7)
- •Fasting glucose >125 (screening test; may reassess once)
- •Use of hypoglycemic drugs (e.g., metformin) for non-diabetic reasons (self-report)
- •Abnormal bleeding or coagulopathy (self-report)
- •◦History of a bleeding disorder or clotting abnormality
- •Thyroid disease (screening test)
- •Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory
- •Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for ≥3 months prior to retesting
- •Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment
- •Pulmonary (self-report)
- •◦Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- •Metabolic bone disease (self-report)
- •History of non-traumatic fracture from a standing height or less
- •Current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen
- •Estrogens, progestins (self-report)
- •◦Supplemental, replacement or therapeutic use of estrogens or progestins within the last 6 months, other than birth control or to control menopausal symptoms
- •Pregnancy (screening test) and pregnancy-related conditions (self-report)
- •Pregnant - pregnancy test performed on day of DXA scan in women of child-bearing potential
- •Post-partum during the last 12 months
- •Lactating during the last 12 months
- •Planning to become pregnant during the participation period
- •Elevated blood pressure readings (screening test)
- •Aged <60 years: Resting Systolic Blood Pressure (SBP) ≥140 mmHg or Resting Diastolic Blood Pressure (DBP) ≥90 mmHg
- •Aged ≥60 years: Resting SBP ≥150 mmHg or Resting DBP ≥90 mmHg
- •Reassessment of BP during screening will be allowed to ensure rested values are obtained
- •Cardiovascular (self-report, screening test, and clinician judgement)
- •Congestive heart failure, coronary artery disease, significant valvular disease, congenital heart disease, serious arrhythmia, stroke, or symptomatic peripheral artery disease (self-report, screening test)
- •Specific criteria used to determine whether a volunteer can undergo the screening Cardiopulmonary Exercise Test (CPET) follow the American Heart Association (AHA) Criteria [54]
- •Inability to complete the CPET
- •Abnormal blood lipid profile (screening test)
- •Fasting triglycerides >500 mg/dL
- •Low-density lipoprotein cholesterol (LDL-C) >190mg/dL
- •Cancer (self-report)
- •History of cancer treatment (other than non-melanoma skin cancer) and not "cancer-free" for at least 2 years
- •Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months
- •Chronic infection (self-report)
- •Infections requiring chronic antibiotic or anti-viral treatment
- •Human Immunodeficiency Virus
- •Individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded
- •Liver enzyme tests (Alanine transaminase, Aspartate transaminase) (screening test)
- •◦>2 times the laboratory upper limit of normal
- •Reassessment during screening may be allowed under some conditions (e.g., recent use of acetaminophen)
- •Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting
- •Chronic renal insufficiency (screening test)
- •Estimated glomerular filtration rate <60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation
- 另有 76 项未显示
结局指标
主要结局
Mitochondrial function
时间窗: Week 12 visit
Tested via a Analysis of Covariance (ANCOVA) with baseline as covariate followed by post-hoc multiple comparisons.
Insulin-stimulated glycogen synthesis in human skeletal muscle cell cultures (HSkMC)
时间窗: Week 12 visit
Tested via a Analysis of Covariance (ANCOVA) with baseline as covariate followed by post-hoc multiple comparisons.
次要结局
未报告次要终点
研究者
研究点 (2)
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