Effect of Entacapone on Bodyweight Loss in Obese Population: A Randomized, Double-blind, Placebo-controlled, Pilot Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage change in bodyweight
研究概览
简要总结
This is a randomized, controlled, double blind clinical trial. The purpose of this study is to investigate the weight loss efficacy of entacapone. In this study, participants are randomly divided into entacapone and placebo groups. The percentage change in body weight, the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat, serum insulin, serum triglyceride and the adverse effects are compared between the two groups.
详细描述
All volunteers should clearly understand the objectives and the risks of the present study. Then, all volunteers should carefully read and sign the informed consent and receive a copy of the signed informed consent. If the volunteer agrees to participate to the present study and signs the informed consent, the volunteer is included. The included participants should be followed up and the case report form should be competed by appointed researchers.
Recruiting stage:
To check whether a volunteer are eligible to participate:
- All volunteers are checked according to the inclusive and the exclusive criteria;
- The clinical nutritionists provide diet and exercise regime to the volunteers.
Grouping stage:
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese which is defined as BMI ≥ 28kg/m2 ;
- •18≤ age ≤60 years;
- •Permanent resident in Xi'an City, Shaanxi Province, China
排除标准
- •Unable to closely follow the diet and exercise regime;
- •Bodyweight changes beyond 4kg within 3 month before participating in this study;
- •Have a history of myocardial infarction or unstable angina within 6 month before participating in this study;
- •With endocrine, neurological, psychiatric or malignant diseases;
- •History of thyroid diseases;
- •Cardiac, hepatic and renal dysfunction;
- •Have a long history of using amcinonide;
- •With intestinal malabsorption;
- •With history of acute or chronic pancreatitis
- •With history of gastrointestinal surgery;
- •With history of bariatric surgery;
- •Using any other pharmacological drugs for weight loss;
- •Addicted to any drugs including alcohol;
- •Diabetes;
研究组 & 干预措施
entacapone
An approach of 200mg entacapone at a time and 4 times a day(0.5 hour after every breakfast, lunch and supper and at 0.5 hours before bedtime) is adopted. Every participant is required to record his/her diet, exercise, and drug intake condition in a standard record card which is provided by the researchers.
干预措施: Entacapone (Drug)
placebo
Except for taking the placebo rather than the entacapone, any intervention in the placebo group is the same with that in the entacapone group.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change in bodyweight
时间窗: Monthly until the 6th month after the 1st intervention
The final result will be assessed six months after intervention
次要结局
- Visceral adipose tissue(Monthly until the 6th month after the 1st intervention)
- Serum adipokines(Monthly until the 6th month after the 1st intervention)
- glucose tolerance index(Monthly until the 6th month after the 1st intervention)
- Changes in body mass index(Monthly until the 6th month after the 1st intervention)
- Waist circumstance(Monthly until the 6th month after the 1st intervention)
- Dyslipidemia index(Monthly until the 6th month after the 1st intervention)
- Adverse effects(Monthly until the 6th month after the 1st intervention)
研究者
Kaichun Wu
Dr.
Air Force Military Medical University, China