The Effect of Liraglutide on Pancreatic Hormones and Its Size
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Volumetric Changes of the Pancreas
研究概览
简要总结
Glucagon-like peptide-1 (GLP-1) is a gastrointestinal hormone used to treat type 2 diabetes and severe overweight (Liraglutide).The two pancreas enzymes: amylase and lipase are slightly elevated in GLP-1 treated compared with placebo-treated individuals. Increased levels of these two enzymes (amylase and lipase) are associated with acute inflammation of the pancreas (acute pancreatitis). In humans treated with GLP-1 (receptor agonist) there have not been found an increased risk of acute pancreatitis.
Animal and cell studies have shown that the increased levels of amylase and lipase in the blood are not due to an inflammatory state but adaptive changes (volume increase) of the pancreas.
The investigators (professor Jens Juul Holst, professor Sten Madsbad) want to investigate whether the increased levels of amylase and lipase in the blood of individuals treated with the GLP-1 analogue Saxenda are due adaptive changes of the pancreas. This will be achieved by measuring amylase and lipase before, during and after treatment with a GLP-1 receptor agonist, and at the same time use advanced scanning equipment (PET-MR) from the Clinical Physiological and Nuclear Medical Department at Rigshospitalet, which can determine any volumetric changes in the pancreas with high reproducibility.
The scan will be centered on the pancreas, other organs are not evaluated why the study is not designed to detect any malignant findings in the pancreas or other organs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 26 og < 50 kg/m2
排除标准
- •Abdominal Diameter >60cm type 1 or type 2 diabetes Heart Failure or Disease Statins Kidney or Liver disease Thyroid Disease Inflammatory Bowel Disease Gastroparesis Cancer Lung disease Psychiatric disease Gastric Bypass operation Previous pancreatitis Increased alcoholic consumption Familiar incidence of multiple endocrine neoplasia Previous treatment with GLP-1 (incretin) based medicine Pacemaker or other non-MR-compatible devices
研究组 & 干预措施
GLP-1 Receptor Agonist (Liraglutide)
3.0mg daily dose
干预措施: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml (Drug)
结局指标
主要结局
Volumetric Changes of the Pancreas
时间窗: 6 weeks
Measurements of the pancreas volumen using magnetic resonance imaging-positron emission tomography based technology
次要结局
- Changes in glycemic index(6 weeks)
- Plasma concentrations of the drug(6 weeks)
- Changes in body weight(6 weeks)
- Other MR based changes in the pancreas (edema, cellularity and structural changes)(6 weeks)
- Plasma concentrations of glucagon, insulin and citrullin(6 weeks)
- Uptake of fluorothymidine tracer in the pancreas measured by PET(4 weeks)
- Changes in Plasma Concentrations of Pancreatic Amylase and Lipase(6 weeks)
研究者
Nicolai Jacob Wewer Albrechtsen
Postdoc, MD, PhD
University of Copenhagen