Prevention of Coronary Heart Disease in Morbidly Obese Patients. Lifestyle Intervention, Low Energy Diet or Bariatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Arterial stiffness
研究概览
简要总结
The changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. The primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.
详细描述
Patients matching the eligibility criteria were divided into two groups (not randomized). One group underwent a 7 weeks Low-Energy-Diet before bariatric surgery, the other group participated in an intensive lifestyle intervention program for 3 months.
Data on arterial stiffness, body weight, body composition, blood pressure, blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Morbidly Obese patients with BMI > 40, or BMI > 35 with comorbidity such as Hypertension, Obstructive Sleep Apnea, Weight Related Osteoarthrosis, Type 2 DM.
排除标准
- •Participation in other weight loss program the last 12 months. Serious psychiatric conditions
结局指标
主要结局
Arterial stiffness
时间窗: 7 weeks and 1 year
Pulse wave velocity and augmentation index
Cardiovascular risk factors
时间窗: 7 weeks and 1 year
Several biomarkers will be examined
次要结局
未报告次要终点
研究者
Jøran Hjelmesæth
Professor
The Hospital of Vestfold