Impact of Bariatric Surgery on the Gut Environment

NCT04345328 | Completed

• 1 other identifier: s59836
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the impact of bariatric surgery on the gut health. Patients operated with Roux-en-Y gastric bypass or sleeve gastrectomy and obese patients who want too loose weight with a traditional weight-loss program, will be followed up for 1 year. In these patients, the investigators will measure toxicity parameters to understand better the health status of their colon after surgery. In a next phase, the measured toxicity will be linked with certain players that might cause this toxicity. Protein metabolites, formed from undigested protein by microbiota in the colon, are expected to be toxic agents for the colon. Therefore, the investigators will investigate the fate of ingested protein once the surgery patients are metabolically stabilized.

Conditions

Bariatric Surgery Candidate

Keywords

Bariatric surgery; Toxicity; Colon; Microbial fermentation

Outcome Measures

Primary Outcomes (2)

• Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery

  Faecal water toxicity : measured with a cell viability test. Toxicity : expressed as the dilution of faecal water at which 50 percent of the cells survive.

  Baseline and 2 weeks, 3 months, 6 months and 1 year after surgery

• Degree of protein assimilation 6-24 months after bariatric surgery

  Protein digestion, malabsorption and fermentation : assessed with stable isotope technology. Digestion and malabsorption : expressed as percent of the administered isotope dose. Fermentation : expressed as percent of maximal dose of the fermentation product that can be formed.

  6-24 months after surgery

Secondary Outcomes (1)

• Degree of fat malabsorption 6-24 months after bariatric surgery

  6-24 months after surgery

Study Arms (3)

Roux-en-Y gastric bypass

Patients who were planned for surgery with Roux-en-Y gastric bypass and were operated

Sleeve Gastrectomy

Patients who were planned for surgery with Sleeve Gastrectomy and were operated

Control group

Obese patients involved in a weight loss program that focuses on diet and lifestyle changes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Surgery patient group was recruited at the University Hospital Leuven. * Obese control group was recruited at the Obesity Clinic of the University Hospital Leuven. * Normal and overweight control group was recruited among the employees and family members from employees of the University Hospital Leuven.

You may qualify if:

• Obese control group in weight loss program (toxicity) : obese but otherwise healthy patients on a weight loss diet (BMI \> 30 kg/m²) in the context of the weight-loss program organised at the Obesity Clinic of University Hospital Leuven.
• Control group (protein assimilation) : normal weight (BMI 25-30 kg/m²) or overweight (BMI 25-30 kg/m²).

You may not qualify if:

• Intake of antibiotics 1 months before the start of the study. Pre-and probiotics, laxatives and anti-diarrhea drugs 2 weeks before the start of the study.
• Surgery patients and control group (toxicity) : Gastrointestinal disease or major abdominal surgery in the past (except from appendectomy and cholecystectomy).
• Surgery patients and control group (protein assimilation) : Lung, liver, kidney and gastrointestinal disease or major abdominal surgery in the past (except from appendectomy, cholecystectomy and bariatric surgery). Vegan, vegetarian, lactose-or gluten-free diet. Pregnant or lactating women and subjects who participated in the last year in a study with irradiation exposure.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Feces Breath Urine

Study Officials

• Kristin Verbeke, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor at the Faculty of Medicine KU Leuven

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: March 23, 2017
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

BE (1)