Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Difference in food cue reactivity between experimental days
研究概览
简要总结
The naturally occurring peptide hormone liver-expressed antimicrobial peptide 2 (LEAP2) in an antagonist/inverse agonist towards the ghrelin receptor. Ghrelin administration has previously been shown to increase food cue reactivity in brain regions related to appetite and reward using functional MRI scans.
The aim of this clinical study is to investigate the effects of LEAP2 infusion on food cue reactivity in brain regions related to appetite and reward. Since LEAP2 is an antagonist/inverse agonist towards the ghrelin receptor we hypothesize, that LEAP2 infusion will decrease food cue reactivity in the above-mentioned regions compared to placebo infusion.
Participants with obesity (BMI 30-50 kg/m2) will be included and complete two experimental days with either LEAP2 or placebo infusion in a randomized crossover manner. On experimental days, participants will undergo a MRI scan with functional and anatomical modalities.
The study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years at the time of inclusion
- •Body mass index 30-50 kg/m2
- •Informed consent
排除标准
- •Anaemia (haemoglobin below normal range)
- •Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
- •Nephropathy (serum creatinine above normal range and/or albuminuria)
- •Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment
- •Regular tobacco smoking or use of other nicotine-containing products
- •Claustrophobia
- •Any ongoing medication that the investigator evaluates would interfere with trial participation.
- •Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses
研究组 & 干预措施
LEAP2 infusion
干预措施: LEAP2 infusion (Other)
Placebo infusion
干预措施: Placebo (Other)
结局指标
主要结局
Difference in food cue reactivity between experimental days
时间窗: time 75 - 135 minutes
The primary endpoint is the change in BOLD signals when viewing pictures of food vs. non-food. Differences will be compared between the two experimental days with infusion of placebo and LEAP2, respectively.
次要结局
- Difference in appetite ratings(From baseline to end of infusion)
- Changes in peptide hormone concentrations(From baseline to end of infusion)
研究者
Anders Englund
Principal Investigator
University Hospital, Gentofte, Copenhagen