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Brief Title: Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Official Title: Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Study ID: NCT02860923
Brief 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.
Detailed Description: The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as well as in people with type 2 diabetes and delays gastric emptying. The underlying mechanisms that mediate the effects of weight involve not only central regions like the hypothalamus and the solitary tractus nucleus and area postrema but also peripheral regions as the gastrointestinal tract. These extra hypothalamic effects are of particular interest in the cases of obesity due to hypothalamic lesions. Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to human GLP-1, a gut derived incretin hormone. Since exenatide causes a dose-dependent weight loss, decreasing concentration of glycosylated haemoglobin as well as improving ß-cell function and systolic blood pressure, it could be an attractive treatment for both type 2 diabetes and obesity. In a double-blind placebo-controlled 24-week trial, it has been recently shown that non diabetic obese patients maintained on exenatide 10µg x 2/j lost significantly more weight than did those on placebo (5.1 kg versus 1.6).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU d'Angers, Angers, , France
CHU de Brest, Brest, , France
CHU de Grenoble, Grenoble, , France
CHU de Lyon, Lyon, , France
APHM, Marseille, , France
Hôpital Bicêtre, Paris, , France
Hôpital Cochin, Paris, , France
Hôpital Européen Georges Pompidou, Paris, , France
Hôpital Pitié Salpétrière (APHP), Paris, , France
Hôpital Haut-Lévêque, Pessac, , France
CHU de Toulouse, Toulouse, , France
Name: Paul Perez, Dr
Affiliation: University Hospital, Bordeaux
Role: STUDY_CHAIR
Name: Blandine Gatta-Cherifi, Pr
Affiliation: University Hospital, Bordeaux
Role: PRINCIPAL_INVESTIGATOR