Metformin and Muscle Recovery Following ACL Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Thigh Muscle Fibrosis
研究概览
简要总结
The purpose of this research study is to determine if Metformin taken after anterior cruciate ligament reconstruction (ACLR) surgery can decrease muscle fibrosis, cellular senescence and improve leg strength. ACL injury and surgery increase muscle collagen content and inflammation which slows the recovery of muscle and function and ultimately impacts the quality of life. Individuals enrolled in the study will be randomized to receive metformin (or placebo) for 4 months after surgery. The investigators will measure muscle strength and inflammatory markers in muscle biopsy samples after the intervention period. Investigators will also follow up with participants 8 months later to determine the lasting effects of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40y and older
- •BMI: <30 kg/m2
- •Full thickness ACL tear
- •Less than 6 months between ACL injury and scheduled ACLR
排除标准
- •Prior ACL tear in limb scheduled for reconstruction or current bilateral ACL tear
- •Total knee dislocation
- •Anticipated quadriceps ACLR grafts
- •Current infection near the lower limb
- •Inability to attend physical therapy sessions
- •Post-operative loading restrictions
- •History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)
- •History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted)
- •History of stroke with motor disability
- •History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
- •Self-reported pregnancy
- •Bleeding disorder
- •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
- •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 will be permitted)
- •Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)
- •Currently taking estrogen products (topical estrogen products will be permitted)
- •Taking anticoagulant medication (warfarin/Coumadin, heparin) that may complicate the muscle biopsy
- •Any staff members who report directly to the principal investigators
研究组 & 干预措施
Placebo
Individuals randomized to placebo group will take the treatment daily for 4 months after ACLR surgery
干预措施: Placebo (Other)
Metformin
Individuals randomized to metformin group will take the intervention daily for 4 months after ACLR surgery
干预措施: Metformin (Drug)
结局指标
主要结局
Thigh Muscle Fibrosis
时间窗: Measured at 4 months after ACLR surgery
Muscle collagen content (% Sirius Red Stain) will be measured in muscle biopsy samples from the involved thigh after 4 months of treatment and compared between the metformin and placebo groups.
Thigh Muscle Cellular Senescence
时间窗: Measured at 4 months following ACLR surgery.
Muscle cellular senescence (% SA Beta galactosidase) will be measured in muscle biopsy samples from the involved thigh after 4 months treatment and will be compared between the metformin and placebo groups
Knee extensor muscle strength
时间窗: Measured at 4 months following ACLR surgery
Knee extensor muscle strength from the involved leg (maximal voluntary isometric contraction; force) will be measured using an isokinetic dynamometer after 4 months of treatment and compared between the metformin and placebo groups.
次要结局
未报告次要终点
研究者
Micah Drummond
Professor
University of Utah