Hormone DeficiencyPhase 2NCT01410799
Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
A Phase 2 study testing Growth Hormone Releasing Hormone (GHRH ) in people with Hormone Deficiency and Aging, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hormone Deficiency, Aging
- What is being tested?
- Growth Hormone Releasing Hormone (GHRH )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2011
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age of 65 years or older
- Fasting IGF-1 level <135ng/ml
- BMI 23-40 kg/m2
- Capable of giving informed consent
Who cannot join
- Diabetes mellitus or use of hypoglycemic agents
- Known coronary artery disease
- Liver disease, abnormal liver function tests (LRTs>2x upper limit of normal) or inflammatory bowel disease
- Renal insufficiency (serum creatinine > or = to 1.4 mg/dL)
- Hematocrit < 33% or > 50%
- History of malignancy < 5 years other than basal cell of the skin
Show all 16Show fewer
- Chronic pulmonary disease or other systemic disorders which affect glucose hemostasis
- Use of growth hormone, corticosteroids, thiazide diuretics, estrogen supplements or androgen supplements
- Inability to perform strength or performance testing
- Uncontrolled hypertension (blood pressure >160/95
- NYHA Class III or IV heart failure
- Current smoking
- Alcohol use > or = to 30g/day
- 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
- Plan to change diet or exercise regimen during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania-UPHS Presbyterian Campus
Philadelphia, Pennsylvania, 19103
About this study
Official title: Three Month Treatment of GHRH (Growth Hormone Releasing Hormone) in the Elderly
The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass, physical performance, and how the body uses sugar.
Read the detailed description
Although multiple factors appear to be associated with the functional deterioration of advanced age, decreases in muscle mass and strength (sarcopenia) are commonly seen in aging subjects and are major risk factors for subsequent disability. There are many potential causes of sarcopenia and functional impairment in the elderly, including medical conditions such as cardiovascular disease, altered mood, and sedentary lifestyle. Hyposomatotropism, or decreased activity of growth hormone (GH), is one factor that has been implicated.
GH is a major anabolic hormone that exerts important stimulatory effects on protein synthesis. Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor 1 (IGF-1) produced systemically by the liver or locally in tissues in response to GH stimulation. IGF-1, in turn, regulates GH secretion by negative feedback mechanisms at the pituitary gland. Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-1 levels. GH levels decline by 14% for each decade after puberty. Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone, decrease in hypothalmic GHRH output, and diminished response to GHRH. The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes. It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition. GH may also increase slow wave (delta or deep) sleep in older adults.
- Conditions
- Hormone Deficiency, Aging
- Being tested
- Growth Hormone Releasing Hormone (GHRH )
- Keywords
- Growth Hormone Releasing Hormone, Growth Hormone Insufficiency, Aging, Growth Hormone, Physiologic Effects of Drugs, Hormones, Hormone Substitutes, and Hormone Antagonists, Hormones
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Hormone Releasing Hormone (GHRH )Drug
Also called Growth Hormone Releasing Factor
GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone Releasing Hormone (GHRH) | Experimental | Drug: GHRH Receives: Drug: Growth Hormone Releasing Hormone (GHRH ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Pre-drug and post-drug 1 RM (Repetition Maximum) testing
Measured: 12 weeks
Secondary outcomes (5)
Glucose Homeostasis
Glucose clamp study at week 12 of study drug use
Measured: 12 weeks
Fat-free and Lean Mass
iDXA scan
Measured: baseline and 12 weeks
Fuel Utilization
Assessment of resting metabolic rate
Measured: baseline and 12 weeks
Physical Performance
6 Minute Walk Test
Measured: Baseline and 12 weeks
Tolerability of Nocturnal Administration
Subjects record diary of drug administration in evening and morning describing any issues with pump system for drug delivery, local skin issues at site of injection or other adverse events. Study nurses also record telephone contact with subjects every other day for first week of dosing and weekly for first month.
Measured: Ongoing throughout 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionAug 2011
Why it stopped: Funding ended
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 Hormone DeficiencyStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dariush Elahi, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410799
- Sponsor's protocol ID
- 813246
- Other IDs
- P01AG000599
- Status last verified
- May 2019
- First submitted
- 17 Jun 2011
- Last updated
- 24 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Month Treatment of GHRH (Growth Hormone Releasing Hormone) in the Elderly
- ClinicalTrials.gov ID
- NCT01410799
- Acronym / sponsor ID
- 813246
- Conditions
- Hormone Deficiency, Aging
- Keywords
- Growth Hormone Releasing Hormone, Growth Hormone Insufficiency, Aging, Growth Hormone, Physiologic Effects of Drugs, Hormones, Hormone Substitutes, and Hormone Antagonists, Hormones
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Posted 24 May 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 the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass, physical performance, and how the body uses sugar.
Detailed description
Although multiple factors appear to be associated with the functional deterioration of advanced age, decreases in muscle mass and strength (sarcopenia) are commonly seen in aging subjects and are major risk factors for subsequent disability. There are many potential causes of sarcopenia and functional impairment in the elderly, including medical conditions such as cardiovascular disease, altered mood, and sedentary lifestyle. Hyposomatotropism, or decreased activity of growth hormone (GH), is one factor that has been implicated.
GH is a major anabolic hormone that exerts important stimulatory effects on protein synthesis. Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor 1 (IGF-1) produced systemically by the liver or locally in tissues in response to GH stimulation. IGF-1, in turn, regulates GH secretion by negative feedback mechanisms at the pituitary gland. Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-1 levels. GH levels decline by 14% for each decade after puberty. Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone, decrease in hypothalmic GHRH output, and diminished response to GHRH. The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes. It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition. GH may also increase slow wave (delta or deep) sleep in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone Releasing Hormone (GHRH) | Experimental | Drug: Growth Hormone Releasing Hormone (GHRH )Drug: GHRH |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age of 65 years or older
- Fasting IGF-1 level <135ng/ml
- BMI 23-40 kg/m2
- Capable of giving informed consent
Key exclusion criteria (16 listed)
- Diabetes mellitus or use of hypoglycemic agents
- Known coronary artery disease
- Liver disease, abnormal liver function tests (LRTs>2x upper limit of normal) or inflammatory bowel disease
- Renal insufficiency (serum creatinine > or = to 1.4 mg/dL)
- Hematocrit < 33% or > 50%
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 |
|---|---|---|
| Growth Hormone Releasing Hormone (GHRH )Also: Growth Hormone Releasing FactorGHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks | Drug | Growth Hormone Releasing Hormone (GHRH) |
Primary outcome
Muscle Strength
Time frame: 12 weeks
Pre-drug and post-drug 1 RM (Repetition Maximum) testing
5 secondary outcomes
Glucose Homeostasis
Time frame: 12 weeks
Fat-free and Lean Mass
Time frame: baseline and 12 weeks
Fuel Utilization
Time frame: baseline and 12 weeks
Physical Performance
Time frame: Baseline and 12 weeks
Tolerability of Nocturnal Administration
Time frame: Ongoing throughout 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 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.
Dariush Elahi, PhD 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 Growth Hormone Releasing Hormone (GHRH ) in people with Hormone Deficiency and 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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 24 May 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. 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 24 May 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?
Muscle Strength (time frame: 12 weeks). 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 24 May 2019.