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

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute on Aging (NIA)
• Treatments: Growth Hormone-Releasing Hormone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

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