Phase 2 N=16 Randomized Quadruple-blind Other

Ghrelin Plus Strength Training in Frail Elderly Study

Frailty Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01898611 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Oct 2018

Primary outcome: Primary: Change in the Short Physical Performance Battery (SPPB) — 0.6; 2.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ghrelin (Drug); Placebo (Drug)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Short Physical Performance Battery (SPPB)	0.6; 2.4	—
PRIMARY Treatment-associated Adverse Events	0; 0	—
SECONDARY Change in Weight	-0.5; 0.88	—
SECONDARY Change in Lean Body Mass	0.7; 1.0	—
SECONDARY Change in Muscle Strength	16; 29	—
SECONDARY Change in Food Intake	298; -81	—
SECONDARY Change in Quality of Life	8; 4	—
SECONDARY Change in Frailty Status	3.2; 3.4	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 2x upper limit of normal)
Hemoglobin 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01898611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.