Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients: Impact on Insulin Sensitivity, Glucose Tolerance, and Pharmacoeconomics
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
- Insulin sensitivity
研究概览
简要总结
The purpose of this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy.
Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Diagnosed with acromegaly
- •Safe anticonceptive for fertile women
- •Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH < 0.5 µg/l.)
排除标准
- •Pregnancy
- •Liver disease
- •Diabetes mellitus type I
- •Magnetic or electronic implants
研究组 & 干预措施
1
Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
干预措施: Pegvisomant (Drug)
1
Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose
干预措施: Somatostatin analog (lanreotide or octreotide) (Drug)
2
Somatostatin analog, unaltered dosage
干预措施: Somatostatin analog (lanreotide or octreotide) (Drug)
结局指标
主要结局
Insulin sensitivity
时间窗: 0 and after 24 weeks
次要结局
- Glucose tolerance(0 and after 24 weeks)
- Symptoms, QoL questionaire(0, 12 and 24 weeks)
- Intrahepatic and intramyocellular fat(0 and 24 weeks)
- Substrate metabolism(0 and 24 weeks)