Muscle Immune Cells During Disuse and Recovery in Aging and Metabolic Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Thigh Muscle Volume
研究概览
简要总结
This is an interventional study enrolling healthy individuals aged 18-35 and 60-85 to understand the recovery of muscle health following a period of inactivity. The enrollment goal is 45 participants. The study will occur over the course of 1-2 months where participants will undergo testing before and after a 2-week limb immobilization period.
详细描述
Visit 1 (Pre-testing)- After signing a consent form, participants will undergo a blood screening and an oral glucose tolerance test. After the visit, participants will be provided with a step activity monitor to track their level of activity. A dietary assessment will also be determined.
Visit 2- At a later time, the participant will return to the research center for a biopsy, blood draw, body composition scan, MRI and muscle strength testing.
2-week leg immobilization period- After visit 2 , the participant will return home and undergo a 14-day leg immobilization period using the equipment and instructions provided at visit 2.
Visit 3- During the limb immobilization period, participant will return to the research center for a single blood draw.
Visit 4- At the end of the 2-week limb immobilization period, the participant will return to the research center to undergo another biopsy, blood draw, body composition scan, MRI and muscle strength testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-35 and 60-85 yrs
- •Ability to sign informed consent
- •Free-living, prior to admission
排除标准
- •History of cardiovascular disease (e.g., CHF, CAD, right-to-left shunt)
- •History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes
- •History of kidney disease or failure
- •Vascular disease
- •Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb>18 g/dL) or thrombocytosis (platelets>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III
- •Use of anticoagulant therapy (e.g., Coumadin, heparin)
- •Elevated systolic pressure >150 or a diastolic blood pressure > 100
- •Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
- •Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
- •Currently on a weight-loss diet
- •Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids are permitted)
- •Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement is permitted)
- •History of stroke with motor disability
- •A recent history (<12 months) of GI bleed
- •History of liver disease
- •History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
- •Pregnancy as determined by a pregnancy test
- •Any staff members who report directly to an investigator or who report to someone who reports directly to an investigator.
- •Any other condition or event considered exclusionary by the PI and faculty physician
研究组 & 干预措施
Limb immobilization
Participants will undergo a 2-week leg immobilization period
干预措施: Limb immobilization (Other)
结局指标
主要结局
Thigh Muscle Volume
时间窗: baseline and after 2 weeks of leg immobilization
change in thigh muscle volume as determined by MRI
Leg Muscle Strength
时间窗: baseline and after 2 weeks of leg immobilization
change in isometric leg extension strength as determined by a isokinetic dynamometer
次要结局
未报告次要终点
研究者
Micah Drummond
Associate Professor
University of Utah