Trials / Recruiting

RecruitingNCT05471037

Different Limb Lengths in Gastric Bypass Surgery (SLIM) - Part 3: Metabolism and Inflammation

Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (SLIM Trial) - Part 3: Metabolic Mechanisms and Inflammatory Response

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 65 (estimated)

Sponsor: University Hospital, Basel, Switzerland · Academic / Other
Sex: All
Age: 18 Years – 65 Years
Healthy volunteers: Accepted

Summary

Investigation of underlying metabolic mechanisms and impact on the two surgical procedures on inflammatory factors.

Detailed description

The aim of this project is to investigate underlying metabolic mechanisms in a subpopulation of patients of the SLIM trial, where a laparoscopic proximal Roux-en-Y gastric bypass (LRYGB) with a longer biliopancreatic limb (BPL) is compared to a standard LRYGB. For this purpose, the aim is to examine differences in number of intestinal enteroendocrine cells, subpopulations of intestinal macrophages, and gene expression or DNA-methylation in tissue samples obtained by colonoscopy from the ileum and transverse colon. In addition, gut microbiota (from colon biopsy and fecal samples), meal-stimulated gut hormone profiles, glycemic control, and metabolite patterns (metabolomics; in blood, urine, stool and breath) including plasma bile acid concentrations preoperatively and 6 months post-surgery will be examined. Body composition (fat mass and lean mass) will be measured by means of BIA (bioimpedance analysis; Biacorpus).

Conditions

Obesity, Morbid

Interventions

Type	Name	Description
PROCEDURE	Long Biliopancreatic Limb LRYGB	LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
PROCEDURE	Short Biliopancreatic Limb LRYGB	Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Timeline

Start date: 2022-08-01
Primary completion: 2026-01-01
Completion: 2026-01-01
First posted: 2022-07-22
Last updated: 2025-01-28

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT05471037. Inclusion in this directory is not an endorsement.