Frailty SyndromePhase 2NCT01898611
Ghrelin Plus Strength Training in Frail Elderly Study
A Phase 2 study testing Ghrelin in people with Frailty Syndrome, 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 Syndrome
- What is being tested?
- Ghrelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 31 Aug 2016
- 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 20Show fewer
- Therapy with megestrol acetate or dronabinol within the last 6 weeks
- Thyroid stimulating hormone measured as < 0.4 uIU/L or greater than 10uIU/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
- Hip fracture of hip or knee replacement within the previous 6 months or unable to walk
- Deemed unsafe to participate by one of the study exercise therapists
- Undergoing physical therapy or an exercise program
- 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)
- Out of town for > 1 week during the 12 week study
- Residing outside of a 15 mile radius of University of Pennsylvania Health System
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104-5160
About this 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 addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.
- Conditions
- Frailty Syndrome
- Being tested
- Ghrelin, Placebo
- Keywords
- Frailty, Sarcopenia, Weight Loss, Exercise, Aging, Ghrelin, Elderly
- Medical subject headings
- Frailty, Sarcopenia, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinDrug
Ghrelin
PlaceboDrug
Saline will be used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Ghrelin plus resistance training | Active comparator | Ghrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training Receives: Drug: Ghrelin |
| Placebo plus resistance training | Placebo comparator | Placebo as a once daily subcutaneous dose for 12 weeks plus resistance training Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Short Physical Performance Battery (SPPB)
The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.
Measured: Baseline to 12 weeks
Treatment-associated Adverse Events
Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).
Measured: Twelve weeks
Secondary outcomes (6)
Change in Weight
Change in weight from baseline to 12 weeks
Measured: Baseline to twelve weeks
Change in Lean Body Mass
Total lean body mass by dual energy x-ray absorptiometry
Measured: Baseline to 12 weeks
Change in Muscle Strength
One repetition max bench press
Measured: Baseline to 12 weeks
Change in Food Intake
Change in food intake by 3-day food intake record
Measured: Baseline to 12 weeks.
Change in Quality of Life
Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points
Measured: Baseline to 12 weeks.
Change in Frailty Status
According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty
Measured: Baseline to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study start1 Jul 2013
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
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 SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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, M.D.,Sc.M., Principal investigator, University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898611
- Sponsor's protocol ID
- 818192
- Status last verified
- Nov 2019
- First submitted
- 2 Jul 2013
- Last updated
- 11 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin Plus Strength Training in Frail Elderly Study
- ClinicalTrials.gov ID
- NCT01898611
- Acronym / sponsor ID
- 818192
- Conditions
- Frailty Syndrome
- Keywords
- Frailty, Sarcopenia, Weight Loss, Exercise, Aging, Ghrelin, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Posted 11 Oct 2018
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 addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ghrelin plus resistance training | Active comparator | Drug: GhrelinGhrelin 7.5 mcg/kg as a once daily subcutaneous dose for 12 weeks plus resistance training |
| Placebo plus resistance training | Placebo comparator | Drug: PlaceboPlacebo as a once daily subcutaneous dose for 12 weeks plus resistance training |
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 (20 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 | Drug | Ghrelin plus resistance training |
| PlaceboSaline will be used as a placebo | Drug | Placebo plus resistance training |
Primary outcome
Change in the Short Physical Performance Battery (SPPB)
Time frame: Baseline to 12 weeks
The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.
Treatment-associated Adverse Events
Time frame: Twelve weeks
Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).
6 secondary outcomes
Change in Weight
Time frame: Baseline to twelve weeks
Change in Lean Body Mass
Time frame: Baseline to 12 weeks
Change in Muscle Strength
Time frame: Baseline to 12 weeks
Change in Food Intake
Time frame: Baseline to 12 weeks.
Change in Quality of Life
Time frame: Baseline to 12 weeks.
Change in Frailty Status
Time frame: Baseline to 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- 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 R. Cappola, M.D.,Sc.M. principal investigator
University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism
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 Syndrome, 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 20 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 11 Dec 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 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 11 Oct 2018). 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?
Change in the Short Physical Performance Battery (SPPB) (time frame: Baseline to 12 weeks). The study lists 2 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 11 Dec 2019.