Ghrelin Repeated Dose Study

Completed · Phase 2

Conditions studied: Frailty in Aging

In brief

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.

Key facts

Study ID

NCT01833078

Run by

University of Pennsylvania

People needed

5

Starts

2013-02-01

Expected to finish

2013-06-01

Last updated by the study team

2015-10-08

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals with three, four or five frailty criteria using the Fried frailty criteria

You may not qualify if…

• 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)

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.