The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Weight Change at 3 months
研究概览
简要总结
This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.
详细描述
Background:The rapid growth of obese or overweight people in the world has become a major social problem. Obese often associated with kinds of metabolic disorders, especially type 2 diabetes, and Liraglutide can effectively reduce weight and improve blood glucose.Previous studies have indicated that most patients will experience different degrees of weight loss after using Liraglutide, but there is also a small number of patients with no significant weight loss.The gene polymorphism among individuals may affect the weight loss effect of Liraglutide.
Objectives：1.To find the relationships between genetic variants and the response of Liraglutide to treatment of obese patients.2.To investigate the effects of Liraglutide on weight, metabolism (blood glucose, blood lipid, uric acid, etc.) and gut microbiota in obese Chinese patients.
Intervention:Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients aged 18 to 65 years (to the date of screening)；
- •The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
- •Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
- •Weight stable for more than 3 months (weight fluctuations <5%).
排除标准
- •Pregnant female.
- •Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.
- •Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
- •Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
- •Nearly a month had surgery, trauma, infection and so on.
- •Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
- •Poor medication compliance or serious side effects (severe rash, syncope, etc.).
研究组 & 干预措施
Liraglutide
Obese patients with HbA1C lower than 9.0%,receive Liraglutide alone for 3 months.
干预措施: Liraglutide (Drug)
Liraglutide combined with metformin
Obese patients with HbA1C ≥9.0%, receive Liraglutide in combination with metformin for 3 months.
干预措施: Liraglutide;metformin (Drug)
结局指标
主要结局
Weight Change at 3 months
时间窗: baseline and 3 months
Measured in kilograms
Genotype
时间窗: baseline
次要结局
- Change in waist circumference(baseline and 3 months)
- Change in diastolic blood pressure(baseline and 3 months)
- Change in HbA1c(baseline and 3 months)
- Change in plasma glucose(baseline and 3 months)
- Change in systolic blood pressure(baseline and 3 months)
- Change in lipids-total cholesterol(baseline and 3 months)
- Change in lipids-high density lipoprotein cholesterol(baseline and 3 months)
- Change in insulin(baseline and 3 months)
- Change in lipids-triglycerides(baseline and 3 months)
- Change in lipids-free fatty acids(baseline and 3 months)
- Change in lipids-low density lipoprotein cholesterol(baseline and 3 months)
- Gut microbiota composition(3 months)
- Change in Uric Acid(baseline and 3 months)