Bariatric Surgery
Conditions
Keywords
bariatric surgery, gastric bypass, sleeve gastrectomy, LDL cholesterol, morbid obesity
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 Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.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.
Interventions
PROCEDUREGastric bypass
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.
PROCEDURESleeve gastrectomy
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.
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The researcher responsible for statistical analysis will be blinded to group allocation until data analysis is complete.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* BMI \>60 kg/m2. * Previous BS. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Hypertriglyceridemia remission postoperatively | 12 months after surgery | Triglyceride concentration \<150 mg/dL without fibrates |
| 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 3 months after surgery | Variation of LDL cholesterol concentration (mg/dL) with respect to preoperative value |
| Changes in total cholesterol during follow-up | At 3 months after surgery | Variation of total cholesterol concentration (mg/dL) with respect to preoperative value |
| Changes in HDL cholesterol during follow-up | At 3 months after surgery | Variation of HDL cholesterol concentration (mg/dL) 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 lipoprotein(a) during follow-up | At 3 months after surgery | Variation of lipoprotein(a) concentration (mg/dL) with respect to preoperative value |
| Changes in lipoproteins particle size | At 3 months postoperatively | Variation of LDL cholesterol particle size (nm) with respect to preoperative value |
| Changes in lipoproteins composition | At 3 months postoperatively | Variation of LDL cholesterol particles concentration (nmol/L) with respect to preoperative value |
| Change in patients' estimated cardiovascular risk | At 3 months postoperatively | Variation of REGICOR score (10-year estimated cardiovascular risk, %) with respect to preoperative value |
| Type 2 diabetes complete remission | At 3 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 3 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 |
| 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 |
| Changes in triglycerides during follow-up | At 3 months after surgery | Variation of triglycerides concentration (mg/dL) with respect to preoperative value |
Countries
Spain
Outcome results
None listed