Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Change of circulating adipokines levels
研究概览
简要总结
Background: Pasireotide treatment is strictly associated with glucose metabolism impairment. The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD).
Methods: Clinical and hormonal parameters, insulin secretion, evaluated by homostasis model assessment (HOMA-β) and by the area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test and insulin sensitivity, evaluated by the euglycemic hyperinsulinemic clamp, were evaluated in 12 patients with active CD before and after 12 months of pasireotide.
Circulating adipokines were evaluated in patients with CD compared to a matched group of 12 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with active Cushing's disease.
排除标准
- •pituitary radiotherapy treatment performed less than 5 years before pasireotide,
- •pregnancy,
- •women taking oral contraceptives,
- •diabetes on GLP-1 analogues,
- •DPP4 inhibitors or sulphonylureas treatment,
- •intolerance to SSA,
- •risk conditions for prolonged QT syndrome and severe liver o renal insufficiency.
研究组 & 干预措施
pasireotide
Pasireotide was administered in a 12 months period
干预措施: Pasireotide 0.6 MG/ML (Drug)
结局指标
主要结局
Change of circulating adipokines levels
时间窗: Change from baseline to 12 months of therapy
Change of homeostasis model assessment (HOMA-β )
时间窗: Change from baseline to 6 and 12 months of therapy
Change of area under the curve (AUC2h) of C-peptide during a mixed meal tolerance test
时间窗: Change from baseline to 6 and 12 months of therapy
Change of M value evaluated by the euglycemic hyperinsulinemic clamp
时间窗: Change from baseline to 12 months of therapy
次要结局
未报告次要终点
研究者
Carla Giordano
Professor
University of Palermo