GRAVITY: GLP-1 analogues in craniopharyngioma
- Conditions
- Craniopharyngioma
- Registration Number
- NL-OMON27692
- Lead Sponsor
- Erasmus MC
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 104
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in BMI
- Secondary Outcome Measures
Name Time Method