Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 11
- 主要终点
- Compare body weight change thanks to weighing machine
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Patients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.
干预措施: Placebo (Drug)
Exenatide
Treatment with exenatide at the initial dose of 5 µg x 2/day (subcutaneously administered) during 4 weeks, and treatment with 10 µg x 2/day during 5 months.
干预措施: Exenatide (Drug)
结局指标
主要结局
Compare body weight change thanks to weighing machine
时间窗: baseline and 6 months
The primary outcome will be assessed by a weighing machine that measure until 200 kg.
次要结局
- Assess cardiovascular risks thanks to lipid profil(6 months)
- Assess eating behaviour thanks to energy intake(6 months)
- Assess cardiovascular risks thanks to glucose profil(6 months)
- Assess energy expenditure thanks to indirect calorimetry(6 months)
- Assess eating behaviour thanks to physiological parameters(6 months)
- Assess eating behaviour thanks to Three factor eating(6 months)
- Assess eating behaviour thanks to visual analogic scales(6 months)
- Assess quality of life thanks to Beck questionnaire(6 months)
- Assess quality of life thanks to ORWELL questionnaire(6 months)
- Assess energy expenditure thanks to physical activity(6 months)
- Treatment tolerance thanks to digestive parameters(6 months)
- Treatment tolerance thanks to dermatologic parameter(6 months)
- Treatment tolerance thanks to pulse rate(6 months)
- Treatment tolerance thanks to Beck scale(6 months)
- Treatment tolerance thanks to HAD scale(6 months)
- Treatment tolerance thanks to enzymatic parameters(6 months)
- Treatment tolerance thanks to glycemia parameter(6 months)
- Assess cardiovascular risks thanks to metabolic parameters(6 months)