Ghrelin in Frail Elderly Subcutaneous Repeated Dose Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety
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 this study, the investigators are trying to find out if repeated daily doses of ghrelin will help frail older people improve food intake for multiple days in a row.
详细描述
The study design is an open label, repeated dose administration study in which we will examine the safety and efficacy of repeated subcutaneous ghrelin administration in frail individuals. There will be a screening visit plus three additional study visits at the CTRC on Days 1, 2, and 7. Participants will receive an injection of ghrelin subcutaneously once daily on Days 1 and 7 and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home. A food record will be kept from Day -3 to Day 6. We will assess the efficacy of repeated ghrelin doses to sustainably increase caloric intake from pre-treatment baseline without hyperglycemia or raising of cortisol levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 mU/L or greater than 10mU/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
- •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)
研究组 & 干预措施
7 day ghrelin dosing - all participants
All participants will receive an injection of ghrelin (7.5mcg/kg) dose subcutaneously once daily on Days 1, 2 and 7 in the research center and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home.
干预措施: ghrelin (Drug)
结局指标
主要结局
Safety
时间窗: pre-treatment baseline through 30 days following the last administration of study treatment day 7
1.Safety: # of participants with treatment emergent adverse events
次要结局
- Sustainability of Increased Caloric Intake(pre-treatment baseline (day 1) through day 7)
研究者
Anne Cappola
Associate Professor of Medicine, Perelman School of Medicine
University of Pennsylvania