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临床试验/EUCTR2010-023179-25-GB
EUCTR2010-023179-25-GB进行中(未招募)不适用

Effects of exenatide on appetite and ghrelin levels in patients with Prader-Willi Syndrome - Effects of exenatide on appetite and ghrelin in Prader-Willi Syndrome

Aintree University Hospital NHS Foundation Trust0 个研究点开始时间: 2011年7月27日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients with Prader-Willi Syndrome with inadequately controlled body weight (BMI > 25 kg/m2), and healthy volunteers (without diabetes), matched for age and adiposity.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • For the Prader Willi Syndrome group: patients with Prader Willi Syndrome with adequately controlled body weight (BMI < 25 kg/m2) will be excluded for safety reasons (see above). Also patients with type 1 or 2 diabetes mellitus will be excluded. Exclusion criteria for control participants have been chosen because they will have a direct influence on eating behaviour and patterns. Participants with the following will be excluded: a history of eating disorder such as bulimia nervosa, anorexia nervosa or binge-eating disorder (according to DSM IV criteria), history of psychiatric disorder (schizophrenia, major depression, bipolar affective disorder), diabetes mellitus (type 1 or 2), current history of excess alcohol consumption or substance abuse or addiction, current (or within last 3 months) use of certain centrally acting medication (certain psychotropic or antidepressant medications) that are known to influence feeding behaviour, a history of traumatic brain injury, genetic forms of hypothalamic obesity (such as Prader-Willi syndrome, Biedl-Bardet syndrome). For all participants: the presence of metal implants or metal objects on the body which cannot be removed (those fitted with a heart pacemaker, mini-defibrillator or neurostimulator or have an artificial heart valve; surgical clips in the head; history of injury which may have left metal particles in the eye, head, or elsewhere in the body) will be excluded from the abdominal MRI aspect of the study, as these factors would pose a safety risk to the participant.

研究者

发起方
Aintree University Hospital NHS Foundation Trust

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