Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Liver volume
研究概览
简要总结
Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery are routinely pre-treated with a low calorie diet in order to reduce liver volume and to facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty acids has similar effects on liver volume, but a prospective comparison of both treatments has not been performed yet. Morbidly obese patients respond differently to surgical stress, due to a number of factors. First, obesity is associated with a low-grade inflammatory state induced by an increased amount of macrophages in adipose tissue. This state is associated with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune response to infections. Second, obesity is associated with an altered cortisol metabolism possibly related to adrenal insufficiency. This could play an important role in the altered response to surgical stress and postoperative complications in obese subjects. Third, obesity is associated with altered erythrocyte function, including decreased erythrocyte deformability and increased aggregation, factors contributing to an impaired microcirculation.
This study has a number of different aims. First, we will compare pre-treatment with the standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the stress response of obese subjects before and erythrocyte function. Third, we will investigate the effect of gastric bypass surgery by comparing values before surgery with values on the first postoperative day and 6 months after surgery regarding to immunological parameters, stress response and erythrocyte function.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females undergoing laparoscopic gastric bypass surgery because of morbid obesity
- •Age between 18 and 65 years
- •Able to fit in the MRI
- •Written informed consent
排除标准
- •Pregnancy
- •Diabetes mellitus type 1
- •Current history of inflammatory, infectious or malignant disease
- •Daily use of anti-inflammatory drugs
- •Contra-indications for MRI imaging
- •Contra-indications for the use of omega-3 fatty acids
研究组 & 干预措施
Low calorie diet
Low calorie diet 2 weeks pre-operatively
干预措施: Low calorie diet (Behavioral)
Omega-3 fatty acid capsules
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
干预措施: Omega-3 fatty acid capsules (Drug)
结局指标
主要结局
Liver volume
时间窗: baseline, after treatment
liver volume of the left hepatic lobe measured by MRI
次要结局
- Peri-operative ex vivo LPS stimulated cytokine production capacity(baseline, operation day, postoperative day 1, follow up 6 months)
- Macrophage infiltration in omentum fat biopsies(Biopsies during gastric bypass surgery)
- Erythrocyte function(baseline, day of surgery, postoperative day 1, follow up 6 months)
- Cortisol response(baseline, operation day, postoperative day 1, follow up 6 months)
- Serum parameters of inflammatory response(baseline, operation day, postoperative day 1, follow up 6 months)
- Assessment of the approach of the gastro-oesophageal junction(During gastric bypass surgery)
- Patient satisfaction with intervention(After the pre-operative treatment)
研究者
Alexander P.J. Houdijk
Dr.
Medical Center Alkmaar