Investigating the effects of different limb lengths in gastric bypass surgery on 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

This study is testing whether changing the length of a specific part of gastric bypass surgery can improve metabolism and reduce inflammation in patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (other)
• Locations: 1 site (Basel)
• Trial ID: NCT05471037 on ClinicalTrials.gov

What this trial studies

This project aims to explore the metabolic mechanisms in patients undergoing laparoscopic Roux-en-Y gastric bypass surgery with varying lengths of the biliopancreatic limb. It compares the long biliopancreatic limb procedure to the standard version, focusing on differences in intestinal cell populations, macrophage subtypes, and gene expression. Additionally, the study will analyze gut microbiota, hormone profiles, glycemic control, and metabolite patterns before and after surgery. Body composition will also be assessed using bioimpedance analysis.

Who should consider this trial

Good fit: Ideal candidates include individuals with morbid obesity (BMI of 35 kg/m2 or higher) who meet Swiss bariatric surgery guidelines and are participating in the SLIM trial.

Not a fit: Patients with a BMI over 60 kg/m2, those with inflammatory bowel disease, or individuals taking immunosuppressive drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how surgical techniques impact metabolic health and inflammation in obese patients.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding metabolic outcomes post-bariatric surgery.

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

Where this trial is running

Basel

• St Clara Research Ltd, St Claraspital Basel — Basel, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Anne Christin Meyer-Gerspach, PD Dr. phil. II Dr. habil. — St. Clara Forschung AG / St. Claraspital AG
• Study coordinator: Ralph Peterli, Prof. Dr. med.

Conditions: Obesity, Morbid