Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Homocysteine Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma
排除标准
- •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
研究组 & 干预措施
A - Normal growth hormone secretion
Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: Blood draws (Procedure)
A - Normal growth hormone secretion
Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: growth hormone releasing hormone (GHRH) & arginine (Drug)
A - Normal growth hormone secretion
Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: Carotid ultrasound (Procedure)
A - Normal growth hormone secretion
Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: MRI (Procedure)
A - Normal growth hormone secretion
Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: Endothelial cell biopsy (Procedure)
B - Growth hormone deficient
Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: Blood draws (Procedure)
B - Growth hormone deficient
Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: growth hormone releasing hormone (GHRH) & arginine (Drug)
B - Growth hormone deficient
Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: Carotid ultrasound (Procedure)
B - Growth hormone deficient
Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: MRI (Procedure)
B - Growth hormone deficient
Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) & arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.
干预措施: Endothelial cell biopsy (Procedure)
结局指标
主要结局
Homocysteine Level
时间窗: Day 1
Homocytsteine levels in GH sufficient and GH deficient participants
C-reactive Protein (CRP) Levels
时间窗: Day 1
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Total Cholesterol Level
时间窗: Day 1
Total cholesterol levels in GH sufficient and GH deficient participants
次要结局
- Insulin Sensitivity as Assessed by Fasting Insulin Levels(Day 1)
- Intramyocellular Lipid Content Using MRI and MR Spectroscopy(Day 1)
- Intrahepatic Lipid Content Using MRI and MR Spectroscopy(Day 1)
- Lean Body Mass by DXA DEXA(Day 1)
- Glucose Levels as Assessed by an Oral Glucose Tolerance Test(Day 1)
- Percentage of Fat Measured by DXA DEXA(Day 1)
- Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound(Year 1)
- Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy(Day 1)
研究者
Pamela U. Freda
Associate Professor of Medicine
Columbia University