NCT03975478

Bariatric Surgery and LDL Cholesterol

BASALTO (Bariatric Surgery and LDL Cholesterol) Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 Cholesterol-lowering drugs will be withdrawn immediately after the surgical intervention to asses LDL cholesterol remission during follow-up.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.

Conditions

• Bariatric Surgery

Interventions

Type	Name	Description
PROCEDURE	Gastric 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.
PROCEDURE	Sleeve 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.

Timeline

• Start date: 2019-07-23
• Primary completion: 2023-02-28
• Completion: 2023-07-01
• First posted: 2019-06-05
• Last updated: 2023-05-24

Locations

1 site across 1 country: Spain