Long-term (up to 3 Years) Clinical and Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues: Open-labeled, Prospective, Parallel Group Study
试验速览
- 阶段
- 4 期
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
研究概览
简要总结
Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.
详细描述
Patients who are diagnosed with acromegaly with a GH-secreting pituitary adenoma receiving TSA at the Asan Medical Center (Seoul, Korea) from Aug 2013 to Aug 2015 will be recruited.
The eligible patient population will consist of 30 adult, male and female patient with Age 18 or older.
- Number of patients by treatment group: Surgical treatment only = 15, Surgery with medical treatment = 15
- Number of Centers: 1 (single center)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age 18 or older.
- •Patients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI, meeting the biochemical criteria outlined above (refer to
- •Diagnosis of acromegaly) and with typical acromegalic features.
- •No prior use of somatostatin analogues.
- •Adequate hepatic and renal function
- •Provision of a signed written informed consent
排除标准
- •Severe co-morbid illness such as untreatable other malignancy and/or active infections.
- •Pregnant or lactating women
- •Hypersensitivity to Sandostatin or any component of the formulation.
研究组 & 干预措施
Group 2: Surgery + Medical treatment
MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml
medical treatment : Sandostatin (Octreotide Acetate)
干预措施: Sandostatin (Octreotide Acetate) (Drug)
结局指标
主要结局
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
时间窗: Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative
The time taken to IGF-1 normalization in each group.
时间窗: Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative
次要结局
- GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose(Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative)
- Clinical symptom and sign with AcroQoL questionnaire(Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative)
- Sleep quality and disturbance with written questionnaire(Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative)
- fasting glucose , postprandial glucose(Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.)
- HbA1c(change from pre-operative in HbA1c at 36 months post-operative.)
- insulin(Change from pre-operative in insulin at 36 months post-operative.)
研究者
min seon kim
principal investigator
Asan Medical Center