A pilot study on the effect of once weekly exenatide compared to treatment as usual for weight loss and glycaemic control in schizophrenia patients with obesity and diabetes

The University of Queensland0 个研究点目标入组 28 人开始时间: 2015年5月26日最近更新: 2023年8月21日

适应症

试验速览

暂无简介。

•Provision of informed consent prior to any study specific procedures
•Clinical diagnosis of Schizophrenia or Schizoaffective Disorder
•On oral clozapine for at least 18 weeks
•Stable body weight (defined as less than 5kg change in weight over the past 3 months before inclusion)
•a) Diagnosis of Type II Diabetes Mellitus
•b) Current and stable therapeutic doses of oral glucose lowering agents for 3 months prior to recruitment
•c) BMI greater than or equal to 30kg/m2 and less than 45kg/m2
•a) BMI greater than or equal to 30kg/m2 and less than 45kg/m2

•Pregnancy or lactation
•Severe gastrointestinal disease
•Severe renal impairment
•Allergy/hypersensitivity to investigational product
•Obesity due to other endocrinologic disorder (e.g Cushing Syndrome)
•Treatment with corticosteroids or other hormone therapy (except oestrogens or thyroxine) for greater than 10 days
•Current use of any weight-lowering therapy or previous surgical treatment of obesity
•Uncontrolled hypertension
•History of thyroid adenoma or carcinoma
•Untreated or uncontrolled hypo/hyperthyroidism
•Acute or chronic pancreatitis or high risk of pancreatitis
•Concurrent use of insulin
•For Arm 2: Diagnosis of Diabetes Mellitus Type I or Type II

发起方