Different Limb Lengths in Gastric Bypass Surgery (SLIM) - Part 3: Metabolism and Inflammation
SLIM - Part 3
Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (SLIM Trial) - Part 3: Metabolic Mechanisms and Inflammatory Response
1 other identifier
interventional
65
1 country
1
Brief Summary
Investigation of underlying metabolic mechanisms and impact on the two surgical procedures on inflammatory factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 29, 2026
April 1, 2026
4.2 years
March 21, 2022
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (35)
glycemic control
pre-OP and 6-8 months post-OP
intestinal glucose absorption rate
pre-OP and 6-8 months post-OP
gastrointestinal peptides
pre-OP and 6-8 months post-OP
intestinal enteroendocrine cells
pre-OP and 6-8 months post-OP
intestinal macrophages
pre-OP and 6-8 months post-OP
- +30 more secondary outcomes
Study Arms (3)
Long Biliopancreatic Limb LRYGB
ACTIVE COMPARATOR25 morbidly obese patients undergoing gastric bypass surgery, participating in SLIM Trial.
Short Biliopancreatic Limb LRYGB
ACTIVE COMPARATOR25 morbidly obese patients undergoing gastric bypass surgery, participating in SLIM Trial.
Control
NO INTERVENTION15 normal weight control group without surgery.
Interventions
LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
Standard LRYGB with a 80 cm BPL and a 180 cm long AL.
Eligibility Criteria
You may qualify if:
- 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
- healthy lean controls
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Clara Research Ltd, St Claraspital Basel
Basel, 4002, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Christin Meyer-Gerspach, PD Dr. phil. II Dr. habil.
St. Clara Forschung AG / St. Claraspital AG
- PRINCIPAL INVESTIGATOR
Bettina Wölnerhanssen, PD Dr. med.
St. Clara Forschung AG / St. Claraspital AG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
July 22, 2022
Study Start
August 1, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
April 29, 2026
Record last verified: 2026-04