Phase 2 N=10 Randomized Triple-blind Other

Ghrelin in Healthy and Frail Older Women

Frailty

Bottom Line

View on ClinicalTrials.gov: NCT00520884 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Kilocalories Consumed — 412; 553 Kilocalorie

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ghrelin Infusion - Healthy (Drug); Ghrelin Infusion - Frail (Drug); Placebo Infusion -Healthy (Other); Placebo Infusion - Frail (Other)
Age: Older Adult · 70+ yrs
Sex: Female
Sponsor: University of Pennsylvania
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Kilocalories Consumed	412; 553	—
PRIMARY Max Change Growth Hormone	0.33; 14.24	—
PRIMARY Max Change Total Ghrelin	-68.6; 1803.2	—
PRIMARY Max Change Active Ghrelin	-9.1; 845.4	—

Summary

The purpose of this research study is to see if giving women a hormone called "ghrelin" will increase levels of growth hormone in the blood and increase appetite. Ghrelin is a naturally occurring hormone that is produced mostly by the stomach and causes secretion of another hormone called growth hormone. It also increases short-term appetite and may lower the amount of inflammation in the body. Some people lose their appetite as they age and have unintentional weight loss. This may be caused by a break in the communication between the stomach and the brain. We are particularly interested in seeing if there is a difference in the effects of ghrelin in older women who have lost weight recently without wanting to and those who have not.

Eligibility Criteria

Inclusion Criteria

Frail group:

Women aged 70 or greater
Able to give informed consent
Undiagnosed weight loss (>5% over the previous year)
Two of the following four criteria (from Fried L et al, 2001): low grip strength, slow walking speed, subjective exhaustion, low levels of physical activity

Healthy group:

Women aged 70 or greater
Able to give informed consent
None of the frailty criteria

Exclusion Criteria

Prior diagnosis of Parkinson's Disease
History of cerebrovascular accident with residual hemiparesis
Hospitalization for treatment of vascular disease (including, coronary heart disease, cerebrovascular disease, peripheral vascular disease) in the past 6 months
Congestive heart failure
Rheumatoid arthritis or other inflammatory conditions
Depression (defined as a score of >11 on the Geriatric Depression Questionnaire)
History of cancer requiring treatment in the past 5 years, with the exception of cancers which have been cured, or, in the opinion of the investigator, carry a good prognosis
Cognitive deficit as defined by a Folstein Mini Mental State Exam score 2x upper limit of normal)
Renal insufficiency (serum creatinine ≥ 1.4 mg/dL).
Hemoglobin 85 kg

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Data sourced from ClinicalTrials.gov (NCT00520884). 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.