Liraglutide Use in Prader-Willi Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive effect and has been associated with weight loss in patients with type 2 diabetes. Liraglutide use in the treatment of PWS is limited to one case report by Cyganek et el (See attached Citation). In this case report, the subject showed improvements in hemoglobin A1c and body weight over 14 weeks.
The investigators plan to examine the use of liraglutide in a single subject with Prader Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Prader Willi Syndrome, Diabetes Type 2
排除标准
- •Previous or family history of Medullary Carcinoma of the Thyroid or multiple endocrine neoplasia syndrome.
- •Subjects with acute or chronic Pancreatitis
研究组 & 干预措施
Liraglutide
Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome
干预措施: Liraglutide (Drug)
结局指标
主要结局
Hemoglobin A1C
时间窗: Change from baseline in A1C at 12 months
次要结局
- Fasting Blood Insulin level(Change from baseline in fasting blood insulin at 12 months)
- Body Weight (kg)(Change from baseline in body weight at 12 months)
- Fasting Lipid Profile(Change from baseline in fasting lipid profile at 12 months)
- Hip Circumference (cm)(Change from baseline in hip circumference at 12 months)
- Fasting Blood Glucose (mmol/L)(Change from baseline in fasting blood glucose at 12 months)
- Total Body Adipose Tissue Distribution (whole body Computed Tomography)(Change from baseline in total body adipose tissue distribution at 12 months)
研究者
David E. Harris, MD
MD, Clinical Endocrinology Fellow, University of British Columbia
Vancouver General Hospital