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

This study has been terminated.
(Funding ended)
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01410799
First received: June 17, 2011
Last updated: December 3, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Hormone Deficiency
Aging
Drug: Growth Hormone Releasing Hormone (GHRH )
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Three Month Treatment of GHRH (Growth Hormone Releasing Hormone) in the Elderly

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Muscle strength [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Pre-drug and post-drug 1 RM (Repetition Maximum) testing


Secondary Outcome Measures:
  • Glucose homeostasis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Glucose clamp study at week 12 of study drug use

  • Fat-free and lean mass [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    iDXA scan

  • Fuel utilization [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Assessment of resting metabolic rate

  • Physical performance [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    6 Minute Walk Test

  • Tolerability of nocturnal administration [ Time Frame: Ongoing throughout 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 13
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410799

Locations
United States, Pennsylvania
University of Pennsylvania-UPHS Presbyterian Campus
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Dariush Elahi, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Dariush Elahi, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01410799     History of Changes
Other Study ID Numbers: 813246, P01AG00599
Study First Received: June 17, 2011
Last Updated: December 3, 2011
Health Authority: United States: Food and Drug Administration

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:
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014