Frailty in AgingPhase 2GRDNCT01833078
Ghrelin Repeated Dose Study
A Phase 2 study testing ghrelin in people with Frailty in Aging, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty in Aging
- What is being tested?
- ghrelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals with three, four or five frailty criteria using the Fried frailty criteria
Who cannot join
- 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
Show all 15Show fewer
- Therapy with megestrol acetate or dronabinol within the last 6 weeks
- Thyroid stimulating hormone measured as < 0.4 mU/L or greater than 10mU/L
- Abnormal liver function tests (LFTs > 2x upper limit of normal)
- Hemoglobin < 11g/dL
- Insulin-like growth factor-I (IGF-I) above the age-specific reference range
- History of surgery within the last 30 days
- Unstable medical or psychological conditions or unstable home or food environment
- Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30
- Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Ghrelin in Frail Elderly Subcutaneous Repeated Dose Study
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.
Read the detailed description
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.
- Conditions
- Frailty in Aging
- Being tested
- ghrelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ghrelinDrug
ghrelin administration subcutaneously for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ghrelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
1.Safety: # of participants with treatment emergent adverse events
Measured: pre-treatment baseline through 30 days following the last administration of study treatment day 7
Secondary outcomes (1)
Sustainability of Increased Caloric Intake
Sustained food intake of standardized meal from Days 1 compared to Day 7.
Measured: pre-treatment baseline (day 1) through day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Frailty in AgingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Cappola, University of Pennsylvania
- Investigators
- Anne Cappola, MD, ScM, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833078
- Sponsor's protocol ID
- 817283
- Acronym
- GRD
- Status last verified
- Sep 2015
- First submitted
- 11 Apr 2013
- Last updated
- 8 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin in Frail Elderly Subcutaneous Repeated Dose Study
- ClinicalTrials.gov ID
- NCT01833078
- Acronym / sponsor ID
- GRD / 817283
- Conditions
- Frailty in Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 8 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7 day ghrelin dosing - all participants | Other | Drug: ghrelinAll 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Individuals with three, four or five frailty criteria using the Fried frailty criteria
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ghrelinghrelin administration subcutaneously for 7 days | Drug | 7 day ghrelin dosing - all participants |
Primary outcome
Safety
Time frame: pre-treatment baseline through 30 days following the last administration of study treatment day 7
1.Safety: # of participants with treatment emergent adverse events
1 secondary outcome
Sustainability of Increased Caloric Intake
Time frame: pre-treatment baseline (day 1) through day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Cappola, MD, ScM principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ghrelin in people with Frailty in Aging, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: pre-treatment baseline through 30 days following the last administration of study treatment day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.