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

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

Recruiting
18-65 years
All
Phase N/A

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Overview

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

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).

Eligibility

Inclusion Criteria:

  • 2 x 25 patients with morbid obestiy (BMI of 35 kg/m2 or higher) who comply with the regulatory rules for bariatric surgery in Switzerland (SMOB guidelines) and participate in the SLIM Trial
  • 15 healthy lean controls

Exclusion Criteria:

  • general contraindications to kind of surgery
  • known or suspected non-compliance
  • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
  • participation in another interventional study
  • BMI > 60 kg/m2
  • height < 145 cm
  • CL length of < 180 cm as measured intraoperatively
  • ASA physical status classification > III
  • inflammatory bowel disease
  • diabetes
  • intake of corticosteroids, anti-inflammatory/ immunosuppressive drugs potentially altering immune cells
  • clinical signs of current infection
  • known anemia (e.g. hemoglobin < 110g/L for males, < 100g/L for females)
  • known neutropenia (e.g. leucocyte count < 1.5 x 10^9/L or ANC < 0.5 x 10^9/L)
  • known immunodeficiency, e.g. HIV
  • known vasculitis, collagenosis
  • known adrenal insufficiency and/or substitution with glucocorticoids
  • risky daily alcohol consumption (> 24g/d for males, > 12g/d for females)
  • drug abuse
  • known liver cirrhosis Child B or C
  • known uncontrolled congestive heart failure
  • known uncontrolled malignant disease
  • currently pregnant or breastfeeding

Study details
    Obesity
    Morbid

NCT05471037

University Hospital, Basel, Switzerland

28 January 2024

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