Status:
TERMINATED
Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Hormone Deficiency
Aging
Eligibility:
All Genders
65+ 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
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 majo...
Eligibility Criteria
Inclusion
- Age of 65 years or older
- Fasting IGF-1 level \<135ng/ml
- BMI 23-40 kg/m2
- Capable of giving informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01410799
Start Date
May 1 2011
End Date
August 1 2011
Last Update
May 24 2019
Active Locations (1)
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1
University of Pennsylvania-UPHS Presbyterian Campus
Philadelphia, Pennsylvania, United States, 19103