A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Growth hormone(GH)
研究概览
简要总结
Growth hormone secreting pituitary adenomas(GHomas) produce excessive GH, stimulating excessive insulin like growth factor 1(IGF-1) synthesis in the liver, thus causing multiple systemic complications. The life expectancy of patients with untreated GHomas is shortened by ten years. The treatment goal of GHomas is to shrink the tumor volume and normalize GH and IGF-1. Under current treatment, only 50-70% of patients get remission. Rosiglitazone is a widely used oral antidiabetic medicine. The investigator's preliminary data showed that rosiglitazone decreased the synthesis of GH and IGF-1 in rat pituitary tumor cells GH3 and hepatocytes respectively. The investigator plan to investigate the efficacy of rosiglitazone in the treatment of patients with GHomas who have not been alleviated by other therapies.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with GHomas confirmed by surgery
- •Patients who did not get biochemical remission: GH nadir after oral glucose tolerance test（OGTT）>1.0ug/L or IGF-1 exceeds age matched normal range
排除标准
- •Patients who were allergic to rosiglitazone
- •Patients with liver or kidney dysfunction, respiratory failure
- •Patients with heart failure
- •Patients with edema
- •Patients with severe hyperlipidemia
- •Patients with osteoporosis or a history of non traumatic fractures
- •Patients with pregnancy and lactation
- •Patients who had received radiation therapy within 3 years
- •Patients who had participated in other clinical trials within 3 months
- •Patients with other neoplastic diseases
- •Patients with mental and neurological disorders
- •Patients with other conditions which were believed not appropriate to take part in the clinical trial
研究组 & 干预措施
Ros
Rosiglitazone：2 times a day, 4mg each time（4mgBid）
干预措施: Rosiglitazone (Drug)
结局指标
主要结局
Growth hormone(GH)
时间窗: 6 months
the decrease of growth hormone(GH)
tumor volume
时间窗: 6 months
the change of tumor volume
insulin like factor 1(IGF-1)
时间窗: 6 months
the decrease of insulin like factor 1(IGF-1)
次要结局
未报告次要终点
研究者
Zhaoyun Zhang
professor
Huashan Hospital