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Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01410799
Recruitment Status : Terminated (Funding ended)
First Posted : August 5, 2011
Results First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hormone Deficiency Aging Drug: Growth Hormone Releasing Hormone (GHRH ) Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three Month Treatment of GHRH (Growth Hormone Releasing Hormone) in the Elderly
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: Growth Hormone Releasing Hormone (GHRH)
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
Other Name: Growth Hormone Releasing Factor


Outcome Measures
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Primary Outcome Measures :
  1. Muscle Strength [ Time Frame: 12 weeks ]
    Pre-drug and post-drug 1 RM (Repetition Maximum) testing


Secondary Outcome Measures :
  1. Glucose Homeostasis [ Time Frame: 12 weeks ]
    Glucose clamp study at week 12 of study drug use

  2. Fat-free and Lean Mass [ Time Frame: baseline and 12 weeks ]
    iDXA scan

  3. Fuel Utilization [ Time Frame: baseline and 12 weeks ]
    Assessment of resting metabolic rate

  4. Physical Performance [ Time Frame: Baseline and 12 weeks ]
    6 Minute Walk Test

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410799


Locations
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United States, Pennsylvania
University of Pennsylvania-UPHS Presbyterian Campus
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
University of Pennsylvania
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Dariush Elahi, PhD University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01410799    
Other Study ID Numbers: 813246
P01AG000599 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2011    Key Record Dates
Results First Posted: May 24, 2019
Last Update Posted: May 24, 2019
Last Verified: May 2019
Keywords provided by University of Pennsylvania:
Growth Hormone Releasing Hormone
Growth Hormone Insufficiency
Aging
Growth Hormone
 Physiologic Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Additional relevant MeSH terms:
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Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs