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

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Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Muscle Strength

Secondary Outcome

 Glucose Homeostasis

Condition

Hormone Deficiency

Intervention

Growth Hormone Releasing Hormone (GHRH )

Study Arms / Comparison Groups

 Growth Hormone Releasing Hormone (GHRH)
Description:  Drug: GHRH

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

13

Start Date

May 2011

Completion Date

August 2011

Primary Completion Date

June 2011

Eligibility 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
      

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Dariush Elahi, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01410799

Organization ID

813246

Secondary IDs

P01AG000599

Responsible Party

Sponsor

Study Sponsor

University of Pennsylvania

Collaborators

 National Institute on Aging (NIA)

Study Sponsor

Dariush Elahi, PhD, Principal Investigator, University of Pennsylvania


Verification Date

May 2019