NCT02920190撤回4 期
Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in Epicardial Fat Thickness
研究概览
简要总结
The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥27 kg/m2
- •At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes [IFG, IGT], hypertension, dyslipidemia)
- •Age > 18 and < 70 years old
排除标准
- •Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®
- •Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
- •Insulin dependent or treated type 2 diabetes
- •Current use of other injectable incretins
- •History of diabetes ketoacidosis
- •Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2
- •Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
- •Clinical or laboratory evidences of chronic active liver diseases
- •Acute or chronic infective diseases
- •Known or suspected allergy to Liraglutide, excipients, or related products
- •Pregnant, breast-feeding or the intention of becoming pregnant
- •Females of childbearing potential who are not using adequate contraceptive methods
研究组 & 干预措施
Liraglutide Group
Experimental
Participants in this group will receive the Liraglutide intervention for 12 months
干预措施: Liraglutide (Drug)
结局指标
主要结局
Change in Epicardial Fat Thickness
时间窗: Baseline, 12 months
Epicardial fat thickness measured in mm via ultrasound
次要结局
- Change in serum immunoglobulins(Baseline, 12 months)
- Change in plasma ceramide levels(Baseline, 12 months)
研究者
James Hoffman, MD
Assistant Professor
University of Miami
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