NCT03986008Unknown3 期
Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月1日最近更新:
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
- 60
- 试验地点
- 1
- 主要终点
- Weight Change at 3 months
研究概览
简要总结
The purpose of this studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.
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
- 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
Benaglutide
Experimental
Benaglutide will be administered three times a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given 10 minutes before each meal.
干预措施: Benaglutide (Drug)
Liraglutide
Active Comparator
Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Weight Change at 3 months
时间窗: baseline and 3 months
Measured in kilograms
Gut microbiota composition
时间窗: 3 months
Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).
次要结局
- Change in waist circumference(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-low density lipoprotein cholesterol(baseline and 3 months)
- Change in lipids-high density lipoprotein cholesterol(baseline and 3 months)
- Change in lipids-triglycerides(baseline and 3 months)
- Change in lipids-free fatty acids(baseline and 3 months)
- Change in Uric Acid(baseline and 3 months)
- Change in interleukin-10(baseline and 3 months)
- Change in tumor necrosis factor(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 insulin(baseline and 3 months)
研究者
研究点 (1)
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