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

• Status: Completed
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Exenatide

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 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.