NL-OMON27692尚未招募不适用
The GRAVITY study: Are Glp-1 analogues in cRAniopharyngioma patients a Valid Intervention to Treat obesitY? A randomized controlled trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Erasmus MC
- 入组人数
- 104
研究概览
简要总结
A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with craniopharyngioma, aged =16 years;
- •BMI =30 kg/m2;
- •No surgical intervention for craniopharyngioma one year before inclusion;
- •Adequate hormone replacement therapy (with or without growth hormone) in the past 4 weeks.
排除标准
- •Pregnancy (wish);
- •Breastfeeding or plan to breastfeed during treatment;
- •Allergy or oversensitivity for GLP-1 analogues or components;
- •Multiple Endocrine Neoplasia syndrome 2 (MEN2 syndrome);
- •Up to second degree family members with medullary thyroid carcinoma;
- •Gastroparesis or severe digestive problems;
- •History of or current pancreatitis;
- •Amylase or lipase above 2 times the upper normal range;
- •Active gallbladder disease;
- •Current depression or suicidal thoughts;
- •Liver failure;
- •Renal impairment measured by Glomerular Filtration Rate (GFR) value less than 30 ml/min/1,73 m6 (less than 60 ml/min/1,73 m^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors);
- •NYHA class IV heart failure;
- •Insulin-dependent diabetes mellitus;
- •Use of another GLP-1 analogue;
- •Succeeded bariatric surgery (=10% weight loss);
- •Extreme fear of needles.
研究者
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