Clinical trial NCT00720902: Adult Growth Hormone Deficiency and Cardiovascular Risk
Official title: Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Growth Hormone Deficiency
Keywords: Growth hormone
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2008-07-23
Enrollment: 7
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: C-reactive Protein (CRP) Levels
timeFrame: Day 1
measure: Homocysteine Level
timeFrame: Day 1
measure: Total Cholesterol Level
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Fat Measured by DXA DEXA
timeFrame: Day 1
measure: Lean Body Mass by DXA DEXA
timeFrame: Day 1
measure: Insulin Sensitivity as Assessed by Fasting Insulin Levels
timeFrame: Day 1
measure: Glucose Levels as Assessed by an Oral Glucose Tolerance Test
timeFrame: Day 1
measure: Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy
timeFrame: Day 1
measure: Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound
timeFrame: Year 1
measure: Intramyocellular Lipid Content Using MRI and MR Spectroscopy
timeFrame: Day 1
measure: Intrahepatic Lipid Content Using MRI and MR Spectroscopy
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University, College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: John C Ausiello, MD
role: STUDY_DIRECTOR
References: