NCT02718950Unknown3 期
Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans
University of Campinas, Brazil0 个研究点目标入组 20 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 主要终点
- Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans
研究概览
简要总结
The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index over 30 kg/m2.
排除标准
- •Hypersensitivity to liraglutide or any of its vehicle components;
- •History of diabetes or pre-diabetes - either by fasting glycemia, oGTT or HbA1c;
- •Previous treatment within the last 3 months with glucagon like peptide-1 agonists, iDPP4 or any medication that is associated with BAT activation, including propranolol and benzodiazepines;
- •Liver diseases, except non-alcoholic steatohepatitis (NASH);
- •Infection by HIV, hepatitis B or hepatitis C;
- •Addiction to cannabis, heroin, morphine, cocaine, benzodiazepines or amphetamine;
- •Obesity induced by other disorders such as Cushing syndrome, hypothyroidism, lipodystrophy
- •Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tricyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium);
- •Current participation (or within the last 3 months) in an organized weight reduction program
- •Currently or previous using within 3 months before screening of pramlintide, sibutramine, orlistat, topiramate, or metformin (either by prescription or as part of a clinical trial)
- •Participation in a clinical trial within the last 3 months prior to screening
- •Simultaneous participation in any other clinical trial of an investigational drug
- •Previous surgical treatment of obesity;
- •Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial
- •Liver enzyme (ALT and AST) above 2.5 x of reference range
- •Pancreatic enzymes (amylase, lipase) above 3 x the reference range
- •Chronic kidney disease stages 3, 4, or 5
- •Relevant inflammatory or acute or chronic infectious disease; hyperthyroidism; neurological, psychiatric, gastrointestinal, respiratory, renal, hepatic or cardiac relevant disease, that could interfere with trial results per the judgment of investigator
- •Any condition that at the discretion of investigator could interfere with treatment adhesion on patient safety
- •Blood donation or transfusion within the last 3 months
- •Pregnancy or intention of pregnancy
- •History of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
- •History of pancreatitis
- •Less than 80% of liraglutide adherence
- •Calcitonin above the reference range at the screening visit.
研究组 & 干预措施
Liraglutide 3.0 mg
Experimental
Subjects will use liraglutide 3.0 mg for 2 weeks.
干预措施: Liraglutide 3.0 mg (Drug)
结局指标
主要结局
Evaluate the effect of liraglutide administration on brown adipose tissue (BAT) activation in humans
时间窗: 2 weeks
Activation of BAT, as considered Standard Uptake Value (SUV) threshold of 2.0 on 18-FDG-PET CT, prior to liraglutide use and after 2 weeks on liraglutide 3.0 mg
次要结局
- Evaluate the effect of liraglutide administration on hypothalamic activation in humans(2 weeks)
- Evaluate the effect of liraglutide administration on non-shivering thermogenesis in humans(2 weeks)
- Evaluate the effect of liraglutide administration on body weight in humans(2 weeks)
- Evaluate the effect of liraglutide administration on metabolic basal rate in humans(2 weeks)
- Evaluate the effect of liraglutide administration on body composition in humans(2 weeks)
研究者
Bruno Geloneze
MD, PhD
University of Campinas, Brazil
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