Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/1/2019 |
| Start Date: | May 2011 |
| End Date: | August 2011 |
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.
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.
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.
Inclusion Criteria:
- Age of 65 years or older
- Fasting IGF-1 level <135ng/ml
- BMI 23-40 kg/m2
- Capable of giving informed consent
Exclusion Criteria:
- 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
- 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
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