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

Obesity, Morbid Clinical Trial

— SLIM - Part 3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471037
• Other study ID #: SLIM - Part 3
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Ralph Peterli, Prof. Dr. med.
• Phone: + 41 61 777 75 01
• Email: ralph.peterli[@]clarunis.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Procedure:
• Long Biliopancreatic Limb LRYGB
LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
• Short Biliopancreatic Limb LRYGB
Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Locations

Country	Name	City	State
Switzerland	St Clara Research Ltd, St Claraspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose tolerance	Change in glucose tolerance as measured by plasma glucose concentrations at 120 minutes after ingestion of a standardized liquid test meal, pre-OP and 6-8 months post-OP.	pre-OP and 6-8 months post-OP
Secondary	glycemic control	Change in glucose variability measured by continuous glucose measurement over 1 week, pre-OP and 6-8 months post-OP.	pre-OP and 6-8 months post-OP
Secondary	intestinal glucose absorption rate	Differences in intestinal glucose absorption rate after ingestion of a standardized liquid test meal measured by 3-OMG	pre-OP and 6-8 months post-OP
Secondary	gastrointestinal peptides	Differences in the release of gastrointestinal peptides after ingestion of a standardized liquid test meal	pre-OP and 6-8 months post-OP
Secondary	intestinal enteroendocrine cells	Differences in number and phenotype (protein expression) of intestinal enteroendocrine cells (from ileum biopsies)	pre-OP and 6-8 months post-OP
Secondary	intestinal macrophages	Differences in the number and phenotype (gene expression, methylation) of intestinal macrophages and subpopulations (from colon biopsies)	pre-OP and 6-8 months post-OP
Secondary	gut microbiota composition	Differences in gut microbiota composition (from colon biopsy and fecal sample)	pre-OP and 6-8 months post-OP
Secondary	bile acids	Differences in bile acids and metabolomic patterns (blood)	pre-OP and 6-8 months post-OP
Secondary	inflammatory profile	Differences in inflammatory profile measured by hsCRP in blood	pre-OP and 6-8 months post-OP
Secondary	enterocyte gene expression	Differences in enterocyte gene expression or DNA-methylation (tissue samples from ileum biopsies)	pre-OP and 6-8 months post-OP
Secondary	appetite-related sensations	Differences in subjective appetite-related sensations (feelings of hunger, prospective food consumption, satiation and fullness) after liquid test meal, assessed with Visual Analog Scales	pre-OP and 6-8 months post-OP
Secondary	body composition	Body composition (measured by Bio Impedance Analysis (BIA))	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 1	Differences in mineral metabolism parameter (creatinine) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 2	Differences in mineral metabolism parameter (phosphate) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 3	Differences in mineral metabolism parameter (calcium) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 4	Differences in mineral metabolism parameter (magnesium) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 5	Differences in mineral metabolism parameter (parathyroid hormone) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 6	Differences in mineral metabolism parameter (calcidiol) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 7	Differences in mineral metabolism parameter (calcitriol) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 8	Differences in mineral metabolism parameter (FGF23) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 9	Differences in mineral metabolism parameter (desoxypyridinoline) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 10	Differences in mineral metabolism parameter (bone alkaline phosphatase (bALP)) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 11	Differences in mineral metabolism parameter (osteocalcin) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 12	Differences in mineral metabolism parameter (sclerostin) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 13	Differences in mineral metabolism parameter (P1NP) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (blood) 14	Differences in mineral metabolism parameter (CTX) in blood samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (stool) 1	Differences in mineral metabolism parameter (phosphate) in feces samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (stool) 2	Differences in mineral metabolism parameter (calcium) in feces samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (stool) 3	Differences in mineral metabolism parameter (magnesium) in feces samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (urine) 1	Differences in mineral metabolism parameter (creatinine) in urine samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (urine) 2	Differences in mineral metabolism parameter (phosphate) in urine samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (urine) 3	Differences in mineral metabolism parameter (calcium) in urine samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (urine) 4	Differences in mineral metabolism parameter (magnesium) in urine samples.	pre-OP and 6-8 months post-OP
Secondary	mineral metabolism (urine) 5	Differences in mineral metabolism parameter (desoxypyridinoline) in urine samples.	pre-OP and 6-8 months post-OP
Secondary	metabolomic patterns	Differences in metabolomic patterns assed in blood sample, urine sample, stool sample and exhaled breath.	pre-OP and 6-8 months post-OP
Secondary	immune response	Differences in immune response biomarkers in blood measured by a cytokine screening assay	pre-OP and 6-8 months post-OP