Status:
TERMINATED
Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Elderly
Eligibility:
All Genders
65-85 years
Phase:
PHASE2
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 th...
Detailed Description
Growth hormone (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 I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00807365
Start Date
December 17 2007
End Date
April 29 2010
Last Update
April 27 2017
Active Locations (2)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114