Hypothalamic Obesity Clinical Trial
Official title:
Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
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.
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).
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