Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This is a prospective, randomized, two-armed study to assess the efficacy and safety of isocaloric dietary restriction in the treatment of obese without diabetic for a period of 4 weeks.
详细描述
This is a randomized, open-label, two arms trial. Based on inclusion and exclusion criteria, 72 eligible patients, who are 18-45 years old, with BMI between 35 to 45kg/m2 are assigned to one of two intervention groups: isocaloric dietary restriction; bariatric surgery. Both groups were given a dietary intervention for a period of 4 weeks (in rigorous supervision confined in inpatient department). The main purpose of this study is to clarify the efficacy of isocaloric dietary restriction, compared to bariatric surgery, in losing weight and improving metabolic factors. This is an investigator-initiated study performed by department of endocrinology and metabolic disease, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 45 years old
- •35 ≤ BMI ≤ 45 kg/m2
排除标准
- •Obesity induced by other endocrinologic disorders
- •Severe gastrointestinal diseases or contraindication for surgery
- •History or newly known of diabetes
- •Use of hypoglycemic medications, antibiotic in the preceding 2 months, or yogurt within 5 days
- •Weight change more than 5% of body weight within the past 3 months
- •Severe or unstable cardiovascular, liver or renal diseases or known cancer
- •History of drug or alcohol abuse or other substance abuse
- •Any mental disorders or current use of antidepressantsPregnancy or lactation or consideration of pregnancy
- •Allergies to specific food ingredients in the intervention
研究组 & 干预措施
isocaloric dietary restriction
Very low caloric diet 400 kcal/d for a week, 600 kcal/d for another week and 800 kcal/d for 2 weeks.
干预措施: isocaloric dietary restriction (Dietary Supplement)
Bariatric surgery
Laparoscopic vertical sleeve gastrectomy
干预措施: isocaloric dietary restriction (Dietary Supplement)
Bariatric surgery
Laparoscopic vertical sleeve gastrectomy
干预措施: Bariatric surgery (Procedure)
结局指标
主要结局
Body weight
时间窗: 4 weeks
Change of body weight (kg) from baseline measured by study personnel.
次要结局
- Energy expenditure(4 weeks)
- Lipid profiles(4 weeks)
- Renal function(4 weeks)
- Liver fat content(4 weeks)
- Waist, hip and neck circumference(4 weeks)
- Body mass index(4 weeks)
- Gut hormones(4 weeks)
- Systolic and diastolic blood pressure(4 weeks)
- Body temperature(4 weeks)
- Glucose metabolism(4 weeks)
- Hepatic function(4 weeks)
- Appetite (the subjective desire to eat)(4 weeks)
- Pulse rate(4 weeks)
- Body composition(4 weeks)
- Endocrine hormones(4 weeks)
- Adverse events(4 weeks)
研究者
Wang Weiqing
professor
Shanghai Jiao Tong University School of Medicine