CompletedPhase 3

Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

France42 participantsStarted 2017-01-11

Plain-language summary

This hypothalamic obesity is associated with serious metabolic and psychosocial consequences. The purpose of the study is to compare the change of body weight after 6 months treatment with 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 upper than 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. 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 upper than 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 (upper than 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare body weight change thanks to weighing machine

Timeframe: baseline and 6 months

Trial details

NCT IDNCT02860923

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-30

View on ClinicalTrials.gov More Craniopharyngiomas trials