Bariatric Surgery and LDL Cholesterol

NCT03975478 | Unknown

• 1 other identifier: 2019/8471/I
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery

Keywords

bariatric surgery; gastric bypass; sleeve gastrectomy; LDL cholesterol; morbid obesity

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol remission 1 year after GB and SG

  Postoperative LDL cholesterol \<130 mg/dL without cholesterol-lowering drugs

  At 12 months after surgery

Secondary Outcomes (36)

• LDL cholesterol remission at 3 months after GB and SG

  At 3 months after surgery

• LDL cholesterol remission at 6 months after GB and SG

  At 6 months after surgery

• LDL cholesterol improvement postoperatively

  At 12 months after surgery

• Hypertriglyceridemia remission postoperatively

  12 months after surgery

• Low HDL cholesterol remission postoperatively

  12 months after surgery

Study Arms (2)

Gastric bypass

ACTIVE COMPARATOR

Bariatric surgery by gastric bypass (GB)

Procedure: Gastric bypass

Sleeve gastrectomy

EXPERIMENTAL

Bariatric surgery by sleeve gastrectomy (SG)

Procedure: Sleeve gastrectomy

Interventions

Gastric bypass PROCEDURE

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.

Gastric bypass

Sleeve gastrectomy PROCEDURE

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.

Sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• BMI \>60 kg/m2.
• Previous 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:

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

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MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• David Benaiges Boix, Dr

  Hospital del Mar (Barcelona, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for statistical analysis will be blinded to group allocation until data analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 5, 2019
• Study Start: July 23, 2019
• Primary Completion: February 28, 2023
• Study Completion: July 1, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)