Phase 2
Completed N=10
Ghrelin in Healthy and Frail Older Women
Source: ClinicalTrials.gov NCT00520884 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Kilocalories Consumed — 412; 553 Kilocalorie
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.
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 | — |
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
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. Informational only — not medical advice.