Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)
研究概览
简要总结
The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough
Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:
- Glucose intolerance despite normalized insulin sensitivity
- Modified peripheral GH activity in peripheral target organs assessed on molecular endpoints
详细描述
Acromegaly is a rare disease usually caused by a benign growth hormone (GH) producing pituitary adenoma. In case of inadequate disease control, the condition is associated with significant morbidity and approximately a doubling of mortality compared to the background population. Medical treatment with somatostatin analogues (SA) has been employed for about 20 years and is a well-established treatment in cases where surgery is impossible or inadequate. The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •> 18 years
- •treated acromegaly
- •considered suitable
排除标准
- •pregnancy
研究组 & 干预措施
surgery treated
10 patients with well-controlled acromegaly for at least 6 months after surgery alone.
Stimulated with genotropin
干预措施: genotropin (Drug)
SA treated
10 patients with well-controlled acromegaly for at least 6 months after SA treatment Stimulated with genotropin
干预措施: genotropin (Drug)
结局指标
主要结局
Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)
时间窗: 3 years
GH (ug/l), IGF-I (ug/l), FFA (mmol/l) , glc (mmol/l) and insulin (pmol/l)
次要结局
- concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I(3 years)