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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 this study, the investigators are trying to find out if repeated daily doses of ghrelin will help frail older people improve food intake for multiple days in a row.
The study design is an open label, repeated dose administration study in which we will examine the safety and efficacy of repeated subcutaneous ghrelin administration in frail individuals. There will be a screening visit plus three additional study visits at the CTRC on Days 1, 2, and 7. Participants will receive an injection of ghrelin subcutaneously once daily on Days 1 and 7 and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home. A food record will be kept from Day -3 to Day 6. We will assess the efficacy of repeated ghrelin doses to sustainably increase caloric intake from pre-treatment baseline without hyperglycemia or raising of cortisol levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 day ghrelin dosing - all participants | Other | All participants will receive an injection of ghrelin (7.5mcg/kg) dose subcutaneously once daily on Days 1, 2 and 7 in the research center and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ghrelin | Drug | ghrelin administration subcutaneously for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 1.Safety: # of participants with treatment emergent adverse events | pre-treatment baseline through 30 days following the last administration of study treatment day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustainability of Increased Caloric Intake | Sustained food intake of standardized meal from Days 1 compared to Day 7. | pre-treatment baseline (day 1) through day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Cappola, MD, ScM | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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Participants were recruited from the outpatient medical practice serving the geriatric population at University of Pennsylvania via an electronic alert to physicians. Ten subjects were screened in order to obtain five eligible participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ghrelin | All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ghrelin | ghrelin: ghrelin administration subcutaneously for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety | 1.Safety: # of participants with treatment emergent adverse events | Posted | Number | participants | pre-treatment baseline through 30 days following the last administration of study treatment day 7 |
|
|
Study enrollment through one month following the final visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ghrelin | ghrelin: ghrelin administration subcutaneously for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tired | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Cappola, PI | University of Pennsylvania | 215-573-5359 | acappola@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D054439 | Ghrelin |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Sustainability of Increased Caloric Intake | Sustained food intake of standardized meal from Days 1 compared to Day 7. | Posted | Median | Full Range | calories | pre-treatment baseline (day 1) through day 7 |
|
|
|
| 0 |
| 5 |
| 4 |
| 5 |
| mild diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| mild and transient abdominal discomfort, rumbling and flatulance | Gastrointestinal disorders | Systematic Assessment |
|
| mild and transient headache | General disorders | Systematic Assessment |
|
| transient feeling of pronounced heartbeat | General disorders | Systematic Assessment |
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| Mild fatigue | General disorders | Systematic Assessment |
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| feeling of laziness | General disorders | Systematic Assessment |
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| D000602 | Amino Acids, Peptides, and Proteins |