Bariatric Surgery and LDL Cholesterol
- Conditions
- Bariatric Surgery
- Interventions
- Procedure: Gastric bypassProcedure: Sleeve gastrectomy
- Registration Number
- NCT03975478
- Lead Sponsor
- Parc de Salut Mar
- Brief Summary
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.
- Detailed Description
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 Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
-
BMI >60 kg/m2.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gastric bypass Gastric bypass Bariatric surgery by gastric bypass (GB) Sleeve gastrectomy Sleeve gastrectomy Bariatric surgery by sleeve gastrectomy (SG)
- Primary Outcome Measures
Name Time Method LDL cholesterol remission 1 year after GB and SG At 12 months after surgery Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs
- Secondary Outcome Measures
Name Time Method LDL cholesterol remission at 6 months after GB and SG At 6 months after surgery Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs
Changes in triglycerides during follow-up At 12 months after surgery Variation of triglycerides concentration (mg/dL) with respect to preoperative value
Changes in lipoprotein(a) during follow-up At 12 months after surgery Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
Changes in lipoproteins composition At 12 months postoperatively Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
Low HDL cholesterol remission postoperatively 12 months after surgery HDL cholesterol concentration \>50 mg/dL in women, or \>40 mg/dL in men
Changes in LDL cholesterol concentration postoperatively At 12 months after surgery Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
Changes in total cholesterol during follow-up At 12 months after surgery Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
Changes in HDL cholesterol during follow-up At 12 months after surgery Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
Changes in lipoproteins particle size At 12 months postoperatively Variation of LDL cholesterol particle size (nm) with respect to preoperative value
Type 2 diabetes complete remission At 12 months postoperatively Glycated hemoglobin \[HbA1c\] value \<6.0% and fasting glucose level \<100 mg/dL without diabetes medications
Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG At 12 months postoperatively Different eligible types: Weight loss, changes in targeted lipidomics, changes in lipoproteins particles size and composition, changes in dietary habits and physical activity, modifications in gut microbiota, gene and protein expression in adipose tissue, changes in gut hormones
LDL cholesterol improvement postoperatively At 12 months after surgery In patients without preoperative cholesterol lowering drugs: Decrease ≥20% in LDL cholesterol concentration (mg/dL) without cholesterol-lowering drugs.
In patients with preoperative cholesterol lowering drugs: Medication withdrawn and LDL cholesterol \>130 mg/dL, or decrease ≥20% in LDL cholesterol concentration without medication withdrawn.Change in patients' estimated cardiovascular risk At 12 months postoperatively Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
LDL cholesterol remission at 3 months after GB and SG At 3 months after surgery Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs
Changes in intima media thickness At 12 months postoperatively Variation of mean intima-media thickness (IMT, in mm) measured ultrasonographically in the far wall of bilateral common carotid arteries with respect to preoperative value
Hypertriglyceridemia remission postoperatively 12 months after surgery Triglyceride concentration \<150 mg/dL without fibrates
Trial Locations
- Locations (1)
Hospital del Mar
🇪🇸Barcelona, Spain