Clinical trial NCT05471037: Different Limb Lengths in Gastric Bypass Surgery (SLIM) - Part 3: Metabolism and Inflammation
Official title: Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (SLIM Trial) - Part 3: Metabolic Mechanisms and Inflammatory Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in glucose tolerance
timeFrame: pre-OP and 6-8 months post-OP
Secondary outcomes:
measure: glycemic control
timeFrame: pre-OP and 6-8 months post-OP
measure: intestinal glucose absorption rate
timeFrame: pre-OP and 6-8 months post-OP
measure: gastrointestinal peptides
timeFrame: pre-OP and 6-8 months post-OP
measure: intestinal enteroendocrine cells
timeFrame: pre-OP and 6-8 months post-OP
measure: intestinal macrophages
timeFrame: pre-OP and 6-8 months post-OP
measure: gut microbiota composition
timeFrame: pre-OP and 6-8 months post-OP
measure: bile acids
timeFrame: pre-OP and 6-8 months post-OP
measure: inflammatory profile
timeFrame: pre-OP and 6-8 months post-OP
measure: enterocyte gene expression
timeFrame: pre-OP and 6-8 months post-OP
measure: appetite-related sensations
timeFrame: pre-OP and 6-8 months post-OP
measure: body composition
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 1
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 2
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 3
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 4
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 5
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 6
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 7
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 8
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 9
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 10
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 11
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 12
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 13
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (blood) 14
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (stool) 1
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (stool) 2
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (stool) 3
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (urine) 1
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (urine) 2
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (urine) 3
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (urine) 4
timeFrame: pre-OP and 6-8 months post-OP
measure: mineral metabolism (urine) 5
timeFrame: pre-OP and 6-8 months post-OP
measure: metabolomic patterns
timeFrame: pre-OP and 6-8 months post-OP
measure: immune response
timeFrame: pre-OP and 6-8 months post-OP
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Clara Research Ltd, St Claraspital Basel
Study officials:
affiliation: St. Clara Forschung AG / St. Claraspital AG
name: Anne Christin Meyer-Gerspach, PD Dr. phil. II Dr. habil.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Clara Forschung AG / St. Claraspital AG
name: Bettina Wölnerhanssen, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: