Central Nervous System Effects of Liraglutide® 3.0 mg on Reward Mechanisms in Obese Patients Without Diabetes, in Relation to Food Addiction. A Randomized, Single-centre, Double-blind, Placebo Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system
研究概览
简要总结
The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes).
According to the study protocol, 70 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.
All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session while being presented with gustatory stimuli. Second, participants will complete behavioural tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated with food intake. Third, metabolic parameters and hormones involved in appetite regulation will be assessed and studied in relation to fMRI.
These measurements will be repeated after 16 weeks in obese individuals. The control group of normal body weight individuals will be evaluated once at Baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 30 kg/m2 and < 40 kg/m2
- •right-handed
- •current non-smokers
- •with stable body weight (<5% reported change during the previous 3 months)
排除标准
- •History of any psychiatric, neurological, cardiovascular, renal or liver disease, malignancies, type 1 and type 2 diabetes mellitus
- •use of centrally acting medication, glucocorticoides, insulin, orlistat
- •any substance abuse
- •food allergies
- •deficits of smell and taste
- •history of pancreatitis
- •family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- •pregnancy
- •contraindications for fMRI
研究组 & 干预措施
Liraglutide 3.0 mg
35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg).
干预措施: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo (Drug)
Placebo
35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Placebo by pen injector.
干预措施: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo (Drug)
结局指标
主要结局
Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system
时间窗: 16 weeks
Bold changes in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in from baseline to 16-week follow-up
次要结局
- changes in glucagon(16 weeks)
- changes in waist circumference(16 weeks)
- change of body weight(16 weeks)
- changes in endocannabinoids(16 weeks)
- changes in ghrelin(16 weeks)
- change in food addiction score(16 weeks)
- changes in fasting blood sugar(16 weeks)
- changes in leptin(16 weeks)
- changes in obestatin(16 weeks)
- changes in reelin(16 weeks)
- BOLD in brain regions involved in the reward system(baseline comparison)
- changes in insulin(16 weeks)
- change in liking(16 weeks)
- change in wanting(16 weeks)
- change in emotional regulation abilities(16 weeks)
研究者
Zoltan Pataky
MD
University Hospital, Geneva