Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Growth hormone levels
研究概览
简要总结
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
详细描述
Aim: To determine the importance of the GIP system in patients with acromegaly who has paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP antagonist (GIP-A).
Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin levels will be included in a placebo-controlled cross-over study. The study consists of two study days with concomitant infusions of A) GIP-A or B) saline (placebo).
A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the literature.
Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J Clin Endocrinol Metab 104(3), 856-862
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under clinical investigation of acromegaly disease with normal kidney function, liver function and hemoglobin levels.
排除标准
- •Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (>170/100 mmHg), current pregnancy
结局指标
主要结局
Growth hormone levels
时间窗: 240 min
Plasma growth hormone area under the curve (AUC)
次要结局
- Glucose levels(240 min)
- GIP levels(240 min)
- Insulin-like growth factor-1 (IGF-1) levels(240 min)
- GLP-1 levels(240 min)
- GLP-2 levels(240 min)
- Plasma triglyceride(240 min)
- Insulin levels(240 min)
- C-peptide levels(240 min)
- Free fatty acids (FFA) levels(240 min)
- Glucagon levels(240 min)
- Ghrelin levels(240 min)
- Plasma prolactin(240 min)
- Plasma cholesterol(240 min)
- Plasma TSH(240 min)
研究者
Mette Høy Jensen
Industrial PhD student
University of Copenhagen