Operated craniopharyngioma with hypothalamic involvement, Craniopharyngioma is a pituitary tumor that often affects the hypothalamus. These patients suffer from an intractable weight gain. This is named hypothalamic obesity. There is presently no drug available to treat this obesity.
Conditions
Interventions
Trade Name: Bydureon
Product Name: Budureon
Pharmaceutical Form: Solution for injection
Sponsors
Eva Marie Erfurth
Lund University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male, non-fertile women or female of childbearing potential using medically approved birth control method aged > 18 years. All have the criteria of hypothalmic obesity, where the MRI of the brain clearly shows an affected hypothalamus. All patients have stable pituitary hormone substitutions when needed, including GH therapy. All patients have a BMI > 27 kg/m2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: b) Exclusion criteria. Pregnant or lactating female. Women of childbearing potential with no effective contraceptive method. Type I Diabetes mellitus (Including LADA) Treatment with antihyperglycemic agents apart from insulin and metformin. History of unexplained pancreatitis, chronic pancreatitis, Stomach or gastric surgery. Allergic reaction to any GLP-1 receptor agonist. Clinical relevant history of gastrointestinal disease associated with nausea and vomiting. Cardiovascular, hepatic, neurological, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effects of Exenatid on Weigth during Caloric Restriction and physical excercise in patients with Craniopharyngioma ;Secondary Objective: The secondary endpoints are improved insulin sensitivity, reduced leptin resistance and improvement in lipid balance. ;Primary end point(s): The primary endpoint is weight reduction.;Timepoint(s) of evaluation of this end point: The study is planned for 1 years. If successful the patients may contimue in the trial for 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cardiovascualr risk profile is evaluated including: Blood pressure, BMI, wais/hip ratio, body composition and lipidprofile, and HOMA-index (insulin sensitivity). ;Timepoint(s) of evaluation of this end point: After 2 years treatment for each patient. | — |
Countries
Sweden
Contacts
Public ContactProfessor
Lund University
Outcome results
None listed