Hypothalamic obesity after craniopharyngioma therapy.
Conditions
Interventions
Trade Name: BYETTA
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Suspension for injection in pre-filled pen
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? They are between 18 and 75 yrs. ? They had been diagnosed with a craniopharyngioma treated by surgery and/or irradiation without sign of recurrence. ? They have a BMI > 30kg/m² with intractable weight gain following therapy for craniopharyngioma. ? They demonstrate at least one other endocrinopathy, as a marker of hypothalamic damage. ? All pituitary deficiencies are correctly treated. ? They gave their written, informed consent before the beginning of the study. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: ? They have type 1 diabetes. ? They have type 2 diabetes treated with insulin. ? Acidocetosis. ? Bariatric surgery ? Previous personal history of thyroid or pancreatic cancer. ? Hypercalcitoninemia. ? They have been previously treated by GLP1 analogs. ? Hypertriglyceridemia > 5g/l ? They had previously demonstrated voluntary weight loss during the three previous months. ? They are under the age of 18 years or over the age of 65 yrs. ? They are maintained on medical treatment against obesity. ? They are receiving supraphysiologic hydrocortisone therapy (> 30 mg/jour). ? Their GH status change during the course of the study. ? Exenatide is contraindicated. ? Psychological and/or medical problems that would create difficulties for the patient to comply with the study protocol are present.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the change of body weight at month 6 after a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.; Secondary Objective: - Compare treatment tolerance in booth groups - Assess exenatid efficacy compare to placebo on: * metabolic and cardiovascular risks factors * glycemia control * eating behaviour * quality of life * energy expenditure ;Primary end point(s): Weight variation.;Timepoint(s) of evaluation of this end point: At 6 months after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Tolerance assessment, - Evolution of : *metabolic and cardiovascular risks factors * glycemia control * eating behaviour * quality of life * energy expenditure ; Timepoint(s) of evaluation of this end point: - after each visit and at the end of the trial, - at the inclusion visit and at the last visit | — |
Countries
France
Contacts
Public ContactClinical trials manager
CHU de Bordeaux
Outcome results
None listed