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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-01-01

Brief Summary

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

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Detailed Description

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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).

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Long Biliopancreatic Limb LRYGB

25 morbidly obese patients undergoing gastric bypass surgery, participating in SLIM Trial.

Group Type ACTIVE_COMPARATOR

Long Biliopancreatic Limb LRYGB

Intervention Type PROCEDURE

LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.

Short Biliopancreatic Limb LRYGB

25 morbidly obese patients undergoing gastric bypass surgery, participating in SLIM Trial.

Group Type ACTIVE_COMPARATOR

Short Biliopancreatic Limb LRYGB

Intervention Type PROCEDURE

Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Control

15 normal weight control group without surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Long Biliopancreatic Limb LRYGB

LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.

Intervention Type PROCEDURE

Short Biliopancreatic Limb LRYGB

Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes