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

• Status: Terminated
• Trial end date: 2010-04-29
• 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 effectiveness of GHRH to raise levels of GH and improve these body tissues. The purpose of the tests is to measure how the body handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Massachusetts General Hospital
• Treatments: Growth Hormone-Releasing Hormone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Criteria

Inclusion Criteria:

• Documentation of low GH levels as assessed by a fasting IGF-1 level <135ng/ml.

• Volunteers whose BMI is above normal range and below extreme obesity (BMI 25-40 kg/m2).

Exclusion Criteria:

• Diabetes.

• Known coronary artery disease.

• Liver, peptic or inflammatory bowel disease. Renal or hematologic disease.

• Hematocrit <30% or >50%.

• Clinically significant prostate hypertrophy.

• Elevated Prostate specific antigen (PSA) (4ng/ml).

• Prostate & breast cancer.

• History of malignancy <5 years other than basal cell of the skin.

• Chronic pulmonary disease or other systemic disorders.

• Use of certain drugs (such as thiazide diuretics, beta-blockers, steroids (except for replacement doses), coumadin, and or androgen supplements).

• Peanut allergy.

• Gross physical impairment.

• Sleep apnea.

• Uncontrolled hypertension(blood pressure >160/95 and or requiring more than two antihypertensive medications).

• A clinically worrisome mammogram in women.

• Exercise training (>2x/wk for 20 min at a level that produces sweating) in the last 6 months.