Ghrelin Plus Strength Training in Frail Elderly Study

University of Pennsylvania

Status and phase: Completed; Phase 2

Conditions: Frailty Syndrome

Treatments: Drug: Ghrelin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01898611

818192

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Diabetes mellitus or fasting glucose ≥ 126 mg/dL
2. Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
3. New York Heart Association Class III or IV congestive heart failure
4. Therapy for cancer in the past 12 months, except non-melanoma skin cancer
5. BMI ≥ 30 kg/m2
6. Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
7. Therapy with megestrol acetate or dronabinol within the last 6 weeks
8. Thyroid stimulating hormone measured as < 0.4 uIU/L or greater than 10uIU/L
9. Abnormal liver function tests (LFTs > 2x upper limit of normal)
10. Hemoglobin < 11g/dL
11. Insulin-like growth factor-I (IGF-I) above the age-specific reference range
12. History of surgery within the last 30 days
13. Hip fracture of hip or knee replacement within the previous 6 months or unable to walk
14. Deemed unsafe to participate by one of the study exercise therapists
15. Undergoing physical therapy or an exercise program
16. Unstable medical or psychological conditions or unstable home or food environment
17. Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30
18. Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)
19. Out of town for > 1 week during the 12 week study
20. Residing outside of a 15 mile radius of University of Pennsylvania Health System

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Ghrelin plus resistance training

Active Comparator group

Description:

Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training

Treatment:

Drug: Ghrelin

Placebo plus resistance training

Placebo Comparator group

Description:

Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training

Treatment:

Drug: Placebo