- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410799
Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
Three Month Treatment of GHRH (Growth Hormone Releasing Hormone) in the Elderly
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- University of Pennsylvania-UPHS Presbyterian Campus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Growth Hormone Releasing Hormone (GHRH)
Drug: 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Strength
Time Frame: 12 weeks
|
Pre-drug and post-drug 1 RM (Repetition Maximum) testing
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Homeostasis
Time Frame: 12 weeks
|
Glucose clamp study at week 12 of study drug use
|
12 weeks
|
Fat-free and Lean Mass
Time Frame: baseline and 12 weeks
|
iDXA scan
|
baseline and 12 weeks
|
Fuel Utilization
Time Frame: baseline and 12 weeks
|
Assessment of resting metabolic rate
|
baseline and 12 weeks
|
Physical Performance
Time Frame: Baseline and 12 weeks
|
6 Minute Walk Test
|
Baseline and 12 weeks
|
Tolerability of Nocturnal Administration
Time Frame: Ongoing throughout 12 weeks
|
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.
|
Ongoing throughout 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dariush Elahi, PhD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 813246
- P01AG000599 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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