NCT06803589招募中1 期
Low-dose Growth Hormone for the Treatment of Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Gastroparesis Cardinal Symptom Index (GCSI)
研究概览
简要总结
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms > 6 months that have not responded satisfactorily to standard treatment.
- •For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of >21
排除标准
- •Known history of GH deficiency, hypothalamic or pituitary disease
- •Prior use of GH therapy
- •Age-adjusted low serum IGF1
- •Women on oral estrogen therapy6
- •Pregnancy or nursing
- •History of malignant solid tumors
- •Obesity (BMI > 30)History of coronary and thromboembolic diseases.
- •History of sarcoidosis
- •History of pituitary surgery
- •History of thyroid nodules.
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
- •Failure to give informed consent.
研究组 & 干预措施
Treatment Group
Experimental
Patients with Gastroparesis
干预措施: Growth Hormone (Drug)
结局指标
主要结局
Gastroparesis Cardinal Symptom Index (GCSI)
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
The Gastroparesis Cardinal Symptom Index (GCSI) is a questionnaire that assesses the severity of gastroparesis symptoms of: nausea, early satiety, postprandial fullness, and upper abdominal pain. Scores range from 0-none to 4-very severe.
次要结局
- Complete Spontaneous Bowel Movements (CSBMs)(Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks)
- Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)(Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks)
研究者
Tisha N. Lunsford
GI and Hepatology Consultant
Mayo Clinic
研究点 (2)
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