Status:
COMPLETED
Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Acromegaly
Growth Hormone Deficiency
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to p...
Detailed Description
The aim of the study is to evaluate the effects of physiologic growth hormone (GH) replacement on cardiovascular risk markers, cardiac autonomic function, arterial distensibility, body composition, an...
Eligibility Criteria
Inclusion
- Age 18-75
- History of acromegaly with biochemical cure documented with a normal oral glucose tolerance test (OGTT) and/or a non-elevated IGF-I without concurrent use of somatostatin analogs, dopamine agonists or GH receptor antagonists. Subjects will have been treated with medication, surgery, radiation, or a combination of these
- At the time of enrollment a minimum of 6 months must have elapsed since surgery.
- No malignancy on colonoscopy performed since the diagnosis of acromegaly
- GHD due to surgical or radiation treatment
- GHD will be defined as a peak plasma GH of less than 5 ng/ml in response to an insulin tolerance test or a GH-releasing hormone (GHRH) plus arginine stimulation test
- GHD will also be diagnosed if IGF-I levels are below 2 standard deviations for the age-sex normal range in a patient with at least two other documented anterior pituitary hormone deficiencies
Exclusion
- Untreated thyroid or adrenal insufficiency. Subjects on replacement therapy must be stable for at least 3 months prior to entry into the study
- History of malignancy except for non-melanoma skin cancer
- Hemoglobin \<11.0 gm/dl
- Uncontrolled hypertension
- Hepatic or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x upper limit of normal (ULN) or creatinine level \>2.5 mg/dl)
- Congestive heart failure (New York Heart Association's classification system Class II-IV congestive heart failure (CHF) will be excluded)
- Unstable cardiovascular disease (coronary artery or cerebrovascular disease) or symptoms within one year prior to entry into the study
- Initiation or discontinuation of gonadal steroid therapy within 3 months of entry
- Diabetes mellitus, impaired fasting glucose, impaired glucose tolerance
- Pregnancy or nursing
- Active carpal tunnel syndrome
- Subjects who have received GH therapy within one year prior to entry into the study
- For female subjects age \>40 a screening mammogram must have been obtained within one year prior to their baseline visit.
- Sensitivity to m-cresol
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00182091
Start Date
August 1 2004
End Date
December 1 2010
Last Update
September 2 2020
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114