Ghrelin Plus Strength Training in Frail Elderly Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in the Short Physical Performance Battery (SPPB)
研究概览
简要总结
Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with three, four or five frailty criteria using the Fried frailty criteria
排除标准
- •Diabetes mellitus or fasting glucose ≥ 126 mg/dL
- •Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
- •New York Heart Association Class III or IV congestive heart failure
- •Therapy for cancer in the past 12 months, except non-melanoma skin cancer
- •BMI ≥ 30 kg/m2
- •Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
- •Therapy with megestrol acetate or dronabinol within the last 6 weeks
- •Thyroid stimulating hormone measured as < 0.4 uIU/L or greater than 10uIU/L
- •Abnormal liver function tests (LFTs > 2x upper limit of normal)
- •Hemoglobin < 11g/dL
- •Insulin-like growth factor-I (IGF-I) above the age-specific reference range
- •History of surgery within the last 30 days
- •Hip fracture of hip or knee replacement within the previous 6 months or unable to walk
- •Deemed unsafe to participate by one of the study exercise therapists
- •Undergoing physical therapy or an exercise program
- •Unstable medical or psychological conditions or unstable home or food environment
- •Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30
- •Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)
- •Out of town for > 1 week during the 12 week study
- •Residing outside of a 15 mile radius of University of Pennsylvania Health System
研究组 & 干预措施
Ghrelin plus resistance training
Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training
干预措施: Ghrelin (Drug)
Placebo plus resistance training
Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Short Physical Performance Battery (SPPB)
时间窗: Baseline to 12 weeks
The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.
Treatment-associated Adverse Events
时间窗: Twelve weeks
Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).
次要结局
- Change in Weight(Baseline to twelve weeks)
- Change in Lean Body Mass(Baseline to 12 weeks)
- Change in Muscle Strength(Baseline to 12 weeks)
- Change in Food Intake(Baseline to 12 weeks.)
- Change in Quality of Life(Baseline to 12 weeks.)
- Change in Frailty Status(Baseline to 12 weeks.)
研究者
Anne Cappola
Division of Endocrinology, Diabetes, and Metabolism
University of Pennsylvania