Adult Growth Hormone Deficiency and Cardiovascular Risk
Registered Phase 4 interventional trial (terminated), with sponsor-posted results. This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.
Registered clinical trial record on ClinicalTrials.gov (NCT00720902). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results, though the sponsor has posted summary results. Status: terminated. Study type: interventional. Phase: Phase 4. Sponsor: Columbia University. Conditions: Growth Hormone Deficiency. Interventions: Blood draws, growth hormone releasing hormone (GHRH) & arginine, Carotid ultrasound, MRI, Endothelial cell biopsy. Summary: This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease. Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease. Primary outcome measures: C-reactive Protein (CRP) Levels; Homocysteine Level; Total Cholesterol Level. Eligibility: Inclusion Criteria: * Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma Exclusion Criteria: * Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of \> 30 mg/day, pregnant or nursing women
This is a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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