Ghrelin Plus Strength Training in Frail Elderly Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Frailty Syndrome

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 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.

Key facts

Study ID

NCT01898611

Run by

University of Pennsylvania

People needed

16

Starts

2013-07-01

Expected to finish

2016-08-31

Last updated by the study team

2019-12-11

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 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

Where it is running

• Clinical and Translational Research Center, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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