FrailtyPhase 1/2NCT00520884
Ghrelin in Healthy and Frail Older Women
A Phase 1/2 study testing Ghrelin Infusion - Healthy and Ghrelin Infusion - Frail in people with Frailty, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Ghrelin Infusion - Healthy and Ghrelin Infusion - Frail
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2008
- Phase
- Phase 1/2
- 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
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Women aged 70 or greater
- Able to give informed consent
- None of the frailty criteria
Who cannot join
- 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)
Show all 24Show fewer
- 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 < 18/30
- Current use of corticosteroids or immune-modulating agents other than topical, ophthalmic, and inhaled preparations, in past 3 months
- Diabetes mellitus
- Thyroid stimulating hormone (TSH) measured as <0.5 U/L or greater than 10 U/L. If participant is taking replacement thyroid hormone, they should be on a stable dose for at least 2 months
- History of liver disease or abnormal liver function tests (LFTs > 2x upper limit of normal)
- Renal insufficiency (serum creatinine ≥ 1.4 mg/dL).
- Hemoglobin < 11g/dL
- History of surgery within the last 30 days.
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
- Participation in an investigational drug study within 6 weeks prior to screening visit
- Self reported history of HIV disease
- Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3 months
- History of alcohol abuse as defined as any one of the following:
- 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24 hr period in the past 12 months; or 3) clinical assessment of alcohol dependence based on two or more positive responses to an alcoholism questionnaire (if confirmed by further probing) or on other evidence available to clinic staff. If any of these exclusion criteria are met, the subject may still be considered eligible if, after an explanation of the importance of limiting alcohol intake during the study, the clinic staff believes that the volunteer can and will limit future alcohol intake to acceptable levels.
- History of gastrectomy
- Current therapy with an appetite stimulant, i.e. medroxyprogesterone acetate, within the last 6 weeks.
- Weight >85 kg
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Clinical and Translational Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study of Ghrelin in Healthy and Frail Older Women
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.
Read the detailed description
Five community-dwelling women aged 70 or over with unintentional weight loss of >5% in the prior year plus at least 2 of the 4 remaining Fried criteria for frailty and five healthy women without any frailty criteria were enrolled. Women with conditions that can cause weight loss or taking an appetite stimulant or corticosteroids were excluded. Each woman completed two 180 minute infusions, one week apart, assigned randomly: a graded ghrelin infusion of 2.5, 5.0, and 10.0 pmol/kg/min for 60 minutes each and an equivalent placebo (saline) infusion. A meal of standardized composition was provided after each infusion and intake quantified. Samples were collected every 30 minutes for growth hormone (GH), and total and active ghrelin. Additional samples were collected every 60 minutes for glucose, insulin, free fatty acids, leptin, adiponectin, resistin, glucagon-like peptide-1 receptor agonists (GLP-1), and cortisol. Adverse events were collected during the infusion and by telephone 24 hours later. Non-parametric methods were used to compare differences in response to the ghrelin and placebo infusions 1) in all women and 2) between frail and healthy women.
- Conditions
- Frailty
- Being tested
- Ghrelin Infusion - Healthy, Ghrelin Infusion - Frail, Placebo Infusion -Healthy, Placebo Infusion - Frail
- Keywords
- frailty, ghrelin, appetite, weight loss
- Medical subject headings
- Frailty, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ghrelin Infusion - HealthyDrug
Also called Healthy Older Women Receiving
At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
Ghrelin Infusion - FrailDrug
Also called Frail Older Women Receiving
At time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min will be infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped.
Placebo Infusion -HealthyOther
Also called Healthy Older Women Receiving
At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
Placebo Infusion - FrailOther
Also called Frail Older Women Receiving
At time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped.
| Study group | Role | What they receive |
|---|---|---|
| Healthy 70+ Women Placebo Infusion | Placebo comparator | Healthy and Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion. Receives: Other: Placebo Infusion -Healthy |
| Frail 70+ Women Placebo Infusion | Placebo comparator | Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion. Receives: Other: Placebo Infusion - Frail |
| Healthy 70+ Women Ghrelin Infusion | Active comparator | Healthy Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion). Receives: Drug: Ghrelin Infusion - Healthy |
| Frail 70+ Women Ghrelin Infusion | Active comparator | Frail Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion at a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion). Receives: Drug: Ghrelin Infusion - Frail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kilocalories Consumed
Kilocalorie consumption from meal of standardized composition during the visit when infusion complete
Measured: After infusion
Max Change Growth Hormone
Maximum growth hormone level change from baseline to 180 minutes
Measured: 180 minutes
Max Change Total Ghrelin
Maximum total ghrelin change from baseline to 180 minutes
Measured: 180 minutes
Max Change Active Ghrelin
Active ghrelin change from baseline to 180 minutes. Active ghrelin=acylated ghrelin.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
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 FrailtyStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 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 R Cappola, MD, ScM, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520884
- Sponsor's protocol ID
- IRB805400
- Status last verified
- May 2019
- First submitted
- 23 Aug 2007
- Last updated
- 13 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ghrelin in Healthy and Frail Older Women
- ClinicalTrials.gov ID
- NCT00520884
- Acronym / sponsor ID
- IRB805400
- Conditions
- Frailty
- Keywords
- frailty, ghrelin, appetite, weight loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Posted 13 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Five community-dwelling women aged 70 or over with unintentional weight loss of >5% in the prior year plus at least 2 of the 4 remaining Fried criteria for frailty and five healthy women without any frailty criteria were enrolled. Women with conditions that can cause weight loss or taking an appetite stimulant or corticosteroids were excluded. Each woman completed two 180 minute infusions, one week apart, assigned randomly: a graded ghrelin infusion of 2.5, 5.0, and 10.0 pmol/kg/min for 60 minutes each and an equivalent placebo (saline) infusion. A meal of standardized composition was provided after each infusion and intake quantified. Samples were collected every 30 minutes for growth hormone (GH), and total and active ghrelin. Additional samples were collected every 60 minutes for glucose, insulin, free fatty acids, leptin, adiponectin, resistin, glucagon-like peptide-1 receptor agonists (GLP-1), and cortisol. Adverse events were collected during the infusion and by telephone 24 hours later. Non-parametric methods were used to compare differences in response to the ghrelin and placebo infusions 1) in all women and 2) between frail and healthy women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy 70+ Women Placebo Infusion | Placebo comparator | Other: Placebo Infusion -HealthyHealthy and Frail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion. |
| Frail 70+ Women Placebo Infusion | Placebo comparator | Other: Placebo Infusion - FrailFrail Women 70 and Older Receive a 3 hour Placebo Infusion of Saline administered in a stepwise fashion in amounts equivalent to the ghrelin infusion. |
| Healthy 70+ Women Ghrelin Infusion | Active comparator | Drug: Ghrelin Infusion - HealthyHealthy Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion). |
| Frail 70+ Women Ghrelin Infusion | Active comparator | Drug: Ghrelin Infusion - FrailFrail Women 70 and Older are administered a 3 hour graded Ghrelin Infusion (the first hour of the ghrelin infusion at a dose of 2.5 pmol/kg/min, increased to a dose of 5.0 pmol/kg/min for one hour, and then increased to the dose of 10 pmol/kg/min for the final hour of the infusion). |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
- Women aged 70 or greater
Key exclusion criteria (24 listed)
- 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
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 |
|---|---|---|
| Ghrelin Infusion - HealthyAlso: Healthy Older Women ReceivingAt time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped. | Drug | Healthy 70+ Women Ghrelin Infusion |
| Ghrelin Infusion - FrailAlso: Frail Older Women ReceivingAt time 0, a graded infusion of Ghrelin of 2.5, 5.0, and 10.0 pmol/kg/min will be infused in one of the IV sites for 60 minutes each, totalling 180 minutes when the infusion will be stopped. | Drug | Frail 70+ Women Ghrelin Infusion |
| Placebo Infusion -HealthyAlso: Healthy Older Women ReceivingAt time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped. | Other | Healthy 70+ Women Placebo Infusion |
| Placebo Infusion - FrailAlso: Frail Older Women ReceivingAt time 0, an infusion of saline will be started in one of the IV sites (an equivalent amount to compare to the Ghrelin infusion) and will be infused in a stepwise fashion continued until 180 minutes, when the infusion will be stopped. | Other | Frail 70+ Women Placebo Infusion |
Primary outcome
Kilocalories Consumed
Time frame: After infusion
Kilocalorie consumption from meal of standardized composition during the visit when infusion complete
Max Change Growth Hormone
Time frame: 180 minutes
Maximum growth hormone level change from baseline to 180 minutes
Max Change Total Ghrelin
Time frame: 180 minutes
Maximum total ghrelin change from baseline to 180 minutes
Max Change Active Ghrelin
Time frame: 180 minutes
Active ghrelin change from baseline to 180 minutes. Active ghrelin=acylated ghrelin.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 R 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 1/2 study testing Ghrelin Infusion - Healthy and Ghrelin Infusion - Frail in people with Frailty, 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 9 inclusion and 24 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 13 Jun 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 13 Jun 2019). 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?
Kilocalories Consumed (time frame: After infusion). The study lists 4 primary outcomes in all. 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 13 Jun 2019.