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.
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 Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
The GB technique consists of a 150-cm antecolic Roux limb with a 25-mm circular pouch-jejunostomy and exclusion of 50 cm of the proximal jejunum.
The SG technique consists of a longitudinal resection of the stomach from the angle of His to approximately 5 cm proximal to the pylorus, using a 35 French bougie inserted along the lesser curvature.
Hospital del Mar
Barcelona, Spain
LDL cholesterol remission 1 year after GB and SG
Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs
Time frame: At 12 months after surgery
LDL cholesterol remission at 3 months after GB and SG
Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs
Time frame: At 3 months after surgery
LDL cholesterol remission at 6 months after GB and SG
Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs
Time frame: At 6 months after surgery
LDL cholesterol improvement postoperatively
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.
Time frame: At 12 months after surgery
Hypertriglyceridemia remission postoperatively
Triglyceride concentration \<150 mg/dL without fibrates
Time frame: 12 months after surgery
Low HDL cholesterol remission postoperatively
HDL cholesterol concentration \>50 mg/dL in women, or \>40 mg/dL in men
Time frame: 12 months after surgery
Changes in LDL cholesterol concentration postoperatively
Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 3 months after surgery
Changes in LDL cholesterol concentration postoperatively
Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 6 months after surgery
Changes in LDL cholesterol concentration postoperatively
Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 12 months after surgery
Changes in total cholesterol during follow-up
Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 3 months after surgery
Changes in total cholesterol during follow-up
Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 6 months after surgery
Changes in total cholesterol during follow-up
Variation of total cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 12 months after surgery
Changes in HDL cholesterol during follow-up
Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 3 months after surgery
Changes in HDL cholesterol during follow-up
Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 6 months after surgery
Changes in HDL cholesterol during follow-up
Variation of HDL cholesterol concentration (mg/dL) with respect to preoperative value
Time frame: At 12 months after surgery
Changes in triglycerides during follow-up
Variation of triglycerides concentration (mg/dL) with respect to preoperative value
Time frame: At 3 months after surgery
Changes in triglycerides during follow-up
Variation of triglycerides concentration (mg/dL) with respect to preoperative value
Time frame: At 6 months after surgery
Changes in triglycerides during follow-up
Variation of triglycerides concentration (mg/dL) with respect to preoperative value
Time frame: At 12 months after surgery
Changes in lipoprotein(a) during follow-up
Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
Time frame: At 3 months after surgery
Changes in lipoprotein(a) during follow-up
Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
Time frame: At 6 months after surgery
Changes in lipoprotein(a) during follow-up
Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value
Time frame: At 12 months after surgery
Changes in lipoproteins particle size
Variation of LDL cholesterol particle size (nm) with respect to preoperative value
Time frame: At 3 months postoperatively
Changes in lipoproteins composition
Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
Time frame: At 3 months postoperatively
Changes in lipoproteins particle size
Variation of LDL cholesterol particle size (nm) with respect to preoperative value
Time frame: At 6 months postoperatively
Changes in lipoproteins composition
Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
Time frame: At 6 months postoperatively
Changes in lipoproteins particle size
Variation of LDL cholesterol particle size (nm) with respect to preoperative value
Time frame: At 12 months postoperatively
Changes in lipoproteins composition
Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value
Time frame: At 12 months postoperatively
Change in patients' estimated cardiovascular risk
Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
Time frame: At 3 months postoperatively
Change in patients' estimated cardiovascular risk
Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
Time frame: At 6 months postoperatively
Change in patients' estimated cardiovascular risk
Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value
Time frame: At 12 months postoperatively
Type 2 diabetes complete remission
Glycated hemoglobin \[HbA1c\] value \<6.0% and fasting glucose level \<100 mg/dL without diabetes medications
Time frame: At 3 months postoperatively
Type 2 diabetes complete remission
Glycated hemoglobin \[HbA1c\] value \<6.0% and fasting glucose level \<100 mg/dL without diabetes medications
Time frame: At 6 months postoperatively
Type 2 diabetes complete remission
Glycated hemoglobin \[HbA1c\] value \<6.0% and fasting glucose level \<100 mg/dL without diabetes medications
Time frame: At 12 months postoperatively
Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG
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
Time frame: At 3 months postoperatively
Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG
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
Time frame: At 6 months postoperatively
Type of mechanisms involved in the different LDL cholesterol remission rates after GB and SG
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
Time frame: At 12 months postoperatively
Changes in intima media thickness
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
Time frame: At 12 months postoperatively
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