Status:
COMPLETED
Ghrelin Repeated Dose Study
Lead Sponsor:
University of Pennsylvania
Conditions:
Frailty in Aging
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Individuals with three, four or five frailty criteria using the Fried frailty criteria
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01833078
Start Date
February 1 2013
End Date
June 1 2013
Last Update
October 8 2015
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104