BASALTO (Bariatric Surgery and LDL Cholesterol) Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- LDL cholesterol remission 1 year after GB and SG
研究概览
简要总结
Background:
Observational studies have shown that gastric bypass is superior to sleeve gastrectomy in terms of LDL cholesterol improvement. If these results are confirmed in randomized controlled trials, pre-surgical LDL cholesterol status should be a point to consider in the surgical procedure election.
Objective:
The primary objective is to compare 1-year LDL cholesterol remission after gastric bypass and sleeve gastrectomy in morbid obese patients.
Methods:
Phase 3, uni-centric, randomized clinical trial, with intention-to-treat analysis to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy with a 12 months follow-up. The inclusion criteria will be patients aged between 18-60 years old with a body mass index ≥40 or ≥35 kg/m2 with a significant obesity related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively (2 months before surgery) and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measures, food intake recall, physical activity questionnaires,intima media thickness, fecal samples for microbiota examinations, fat tissue samples and serum samples for lipidomics and hormonal analyses.
详细描述
In the preoperative period, patients will follow a standard nutritional intervention that includes 6 monthly group sessions focused on achieving changes in dietary habits and hence ease adaptation after surgery.
In addition, lipid-lowering treatment will be adjusted and standardized following the Institut Català de la Salut clinical practice guidelines. Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.
After surgery, a standardized protocol will be followed for the two groups in relation to dietary recommendations and physical activity, as well as the initiation of lipid-lowering medication after the intervention, in order to avoid the bias that may arise due to an open study.
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
- Single (Outcomes Assessor)
盲法说明
The researcher responsible for statistical analysis will be blinded to group allocation until data analysis is complete.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≥40 or BMI ≥35 kg/m2 with a significant obesity related comorbidities.
- •Age 18 - 60 years.
- •Previous successfully instituted and supervised but failed adequate diet and exercise program.
- •Elevated LDL cholesterol defined as LDL cholesterol concentration >130 mg/dL or treatment with cholesterol-lowering drugs.
排除标准
- •BMI >60 kg/m
- •Previous BS.
- •Exclusion criteria for BS:
- •Significant psychiatric disorder.
- •Severe eating disorder, active alcohol or substance abuse.
- •Contraindications for major abdominal surgery.
- •Active gastric ulcer disease.
- •Severe hepatic diseases.
- •Pregnancy or breastfeeding.
- •Cases in whom SG or GB are preferred:
- •Severe symptomatic gastro esophageal reflux disease despite medication.
- •Large hiatal hernia.
- •Expected dense adhesions at the level of the small bowel.
- •Need for endoscopic follow-up of the duodenum, history of inflammatory bowel disease.
- •History of renal transplantation in which drug malabsorption can be caused with a GB.
- •Cholesterol lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up. Cases in whom perioperative statins withdrawn cannot be adequate will be excluded:
- •Established cardiovascular disease or subclinical cardiovascular disease (atheroma plaque detection in carotid ultrasonography exam) in which LDL cholesterol objectives are more aggressive or statins can be prescribed independently of LDL cholesterol levels.
- •LDL cholesterol >190 mg/dL or history of familial hypercholesterolemia.
结局指标
主要结局
LDL cholesterol remission 1 year after GB and SG
时间窗: At 12 months after surgery
Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs
次要结局
- LDL cholesterol remission at 6 months after GB and SG(At 6 months after surgery)
- Changes in triglycerides during follow-up(At 12 months after surgery)
- Changes in lipoprotein(a) during follow-up(At 12 months after surgery)
- Changes in lipoproteins composition(At 12 months postoperatively)
- Low HDL cholesterol remission postoperatively(12 months after surgery)
- Changes in LDL cholesterol concentration postoperatively(At 12 months after surgery)
- Changes in total cholesterol during follow-up(At 12 months after surgery)
- Changes in HDL cholesterol during follow-up(At 12 months after surgery)
- Changes in lipoproteins particle size(At 12 months postoperatively)
- Type 2 diabetes complete remission(At 12 months postoperatively)
- Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG(At 12 months postoperatively)
- LDL cholesterol improvement postoperatively(At 12 months after surgery)
- Change in patients' estimated cardiovascular risk(At 12 months postoperatively)
- LDL cholesterol remission at 3 months after GB and SG(At 3 months after surgery)
- Changes in intima media thickness(At 12 months postoperatively)
- Hypertriglyceridemia remission postoperatively(12 months after surgery)