A Phase 2 interventional study of Growth Hormone Releasing Hormone (GHRH ) in Hormone Deficiency and Aging, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment
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.
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.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: GHRH
Drug: Growth Hormone Releasing Hormone (GHRH )
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
Also known as: Growth Hormone Releasing Factor
Muscle Strength
Pre-drug and post-drug 1 RM (Repetition Maximum) testing
Time frame: 12 weeks
Glucose Homeostasis
Glucose clamp study at week 12 of study drug use
Time frame: 12 weeks
Fat-free and Lean Mass
iDXA scan
Time frame: baseline and 12 weeks
Fuel Utilization
Assessment of resting metabolic rate
Time frame: baseline and 12 weeks
Physical Performance
6 Minute Walk Test
Time frame: 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.
Time frame: Ongoing throughout 12 weeks
| Milestone | Growth Hormone Releasing Hormone (GHRH) |
|---|---|
| Started | 13 |
| Completed | 0 |
| Not completed | 13 |
| Withdrew: Pi decision | 13 |
Pre-drug and post-drug 1 RM (Repetition Maximum) testing
No measurements were reported for this outcome.
Glucose clamp study at week 12 of study drug use
No measurements were reported for this outcome.
iDXA scan
No measurements were reported for this outcome.
Assessment of resting metabolic rate
No measurements were reported for this outcome.
6 Minute Walk Test
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Growth Hormone Releasing Hormone (GHRH) | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Event | Growth Hormone Releasing Hormone (GHRH) |
|---|---|
| FatigueEndocrine disorders | 1/13 |
| Age, Categorical(Participants) | Growth Hormone Releasing Hormone (GHRH) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 13 |
| Sex/Gender, Customized(Participants) | Growth Hormone Releasing Hormone (GHRH) |
|---|---|
| Male or Female | NA |
| Race and Ethnicity Not Collected(Participants) | Growth Hormone Releasing Hormone (GHRH) |
|---|
| Region of Enrollment(Participants) | Growth Hormone Releasing Hormone (GHRH) |
|---|---|
| United States | 13 |
This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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