Hormonal and Metabolic Responses to Oral Glucose During Somatostatin Analog Use
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Growth hormone response to OGTT
研究概览
简要总结
The purpose of this study is to test the effect of long-acting somatostatin analog medications, taken by patients with acromegaly or carcinoid syndrome, on growth hormone in comparison to healthy controls who are not receiving the medication in order to see whether or not the medication makes the oral glucose test less accurate. The Oral Glucose Tolerance Test (OGTT) is a standard test to measure growth hormone secretion. By comparing GH responses in non-acromegaly subjects taking somatostatin analog treatment, the relative contribution of the medication and the underlying disease state can be analyzed.
详细描述
Subjects will be informed of the study and after providing written informed consent, subjects will be asked to undergo a 2-hour oral glucose tolerance test (ingestion of 75g glucose with subsequent timed assessment of growth hormone, glucose, insulin and related binding proteins.) Baseline assessment of hormones that may contribute to the results will be drawn, prior to performing the test. Patients will be asked to complete one visit total to participate in this trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of acromegaly or carcinoid syndrome
- •Treatment with somatostatin analog therapy (must have established a stable dose of three or more injections on the same dose prior to study enrollment)
- •Healthy control subjects
排除标准
- •Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
- •Use of medication for the treatment of insulin resistance or diabetes
结局指标
主要结局
Growth hormone response to OGTT
时间窗: 2 hours
assessment of the validity of GH suppression during somatostatin analog treatment in acromegaly and non-acromegaly subjects
次要结局
未报告次要终点
研究者
Odelia Cooper
Professor of Medicine
Cedars-Sinai Medical Center