Aging and the Mitochondrial Response to Exercise Training, Measured by Noninvasive 31P Magnetic Resonance Spectroscopy (MoTrMito)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Post-training 31P MRS measurement - Phosphocreatine recovery rate
研究概览
简要总结
The goal of the study is to determine whether aerobic or resistant exercise can improve in vivo mitochondrial capacity of skeletal muscle cells similarly in healthy younger, middle aged and older adults. This 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.
详细描述
The goal of the study is to understand the biological pathways and molecules driving the exercise response variation of the muscle mitochondria in vivo to elucidate the underlying mechanisms for the health benefits of exercise training in young, middle aged and older adults. This knowledge will improve investigators understanding of biological basis for targeted "precision medicine" exercise and non-exercise interventions to improve age related conditions. The mitochondrial capacity measurement via non-invasive 31P magnetic resonance spectroscopy (31-MRS) will provide a tangible link between the two primary foci of the parent MoTrPAC study: molecular drivers of exercise response and key phenotypic health outcomes.
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 - YOUNG PARTICIPANTS
- •Willingness to provide informed consent to participate in the MoTrMito Study
- •Must be able to read and speak English well enough to provide informed consent and understand instructions
- •Aged 18 - 39 y
- •Body Mass Index (BMI) >19 to <35 kg/m2
- •ADULT PARTICIPANT INCLUSION CRITERIA - MIDDLE AGE PARTICIPANTS
- •Willingness to provide informed consent to participate in the MoTrMito Study
- •Must be able to read and speak English well enough to provide informed consent and understand instructions
- •Aged 40 - 59 y
- •Body Mass Index (BMI) >19 to <35 kg/m2
- •ADULT PARTICIPANT INCLUSION CRITERIA - OLD AGE PARTICIPANTS
- •Willingness to provide informed consent to participate in the MoTrMito Study
- •Must be able to read and speak English well enough to provide informed consent and understand instructions
- •Aged >=60 y
- •Body Mass Index (BMI) >19 to <35 kg/m2
排除标准
- •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 MoTrMito 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
- •Reassessment may be allowed under some conditions (e.g., questionable hydration status or other acute renal insult)
- •Hematocrit (screening test)
- •Hematocrit >3 points outside of the local normal laboratory ranges for women and men Reassessment may be allowed under certain conditions
- 另有 71 项未显示
结局指标
主要结局
Post-training 31P MRS measurement - Phosphocreatine recovery rate
时间窗: After week 12 visit - after all muscle biopsies and exercise training.
The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.
Pre-training 31P MRS measurement - Phosphocreatine recovery rate
时间窗: Baseline visit - before any muscle biopsies or exercise training.
The plot of PCr peak height vs. time will be fitted with a mono-exponential equation whose free parameters are the recovery time constant (tau) and scaling coefficients. Percent change in tau between pre- and post-intervention scans will be our primary measurement of the maximal mitochondrial capacity response to exercise training.
次要结局
未报告次要终点
研究者
Owen Carmichael
Director Biomedical Imaging Center
Pennington Biomedical Research Center