Overview

This trial is active, not recruiting.

Condition frailty syndrome
Treatments ghrelin, resistance training
Phase phase 2
Sponsor University of Pennsylvania
Start date July 2013
End date August 2014
Trial size 16 participants
Trial identifier NCT01898611, 818192

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Active Comparator)
Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training
ghrelin
2:1 ratio placebo to ghrelin
resistance training
The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.
(Placebo Comparator)
Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training
resistance training
The exercise intervention will focus on twice weekly progressive strength training, taught by a certified fitness professional, to be performed in the home using dumbbells, an exercise step, and ankle weights.

Primary Outcomes

Measure
Change between time points in the Short Physical Performance Battery (SPPB)
time frame: Baseline, six and twelve weeks
Safety as measured by number of adverse events
time frame: Baseline, six, and twelve weeks

Secondary Outcomes

Measure
Weight
time frame: Baseline and twelve weeks
Body composition by DXA
time frame: Baseline and twelve weeks
Muscle strength
time frame: Baseline, six weeks, and 12 weeks
Food intake
time frame: Baseline, six weeks, and 12 weeks.
Quality of life
time frame: Baseline, six weeks, and 12 weeks.
Frailty status
time frame: Baseline and 12 weeks.
Acceptability and feasibility of home administration
time frame: Baseline to 12 weeks

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

Official title Ghrelin Plus Strength Training in Frail Elderly Study
Principal investigator Anne R. Cappola, M.D.,Sc.M.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University of Pennsylvania.