Status:
COMPLETED
Impact of Bariatric Surgery on the Gut Environment
Lead Sponsor:
KU Leuven
Conditions:
Bariatric Surgery Candidate
Eligibility:
All Genders
18-80 years
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 loo...
Detailed Description
To quantify protein assimilation after bariatric surgery, the investigators will perform in bariatric surgery patients (Roux-en- Y gastric bypass and Sleeve Gastrectomy) and in a control group a cross...
Eligibility Criteria
Inclusion
- Surgery patients (toxicity and protein assimilation) : BMI \> 40 kg/m² or \> 35 kg/m² if combined with either obstructive sleep apnoea syndrome, high blood pressure not controllable with 3 different medications or type II diabetes, (3) exclusion of other underlying causes of obesity by an endocrinologist, (4) having tried to lose weight on a non-surgical way for at least 1 year without result and (5) a positive advice from a multidisciplinary team consisting of a surgeon, endocrinologist, psychologist and dietitian.
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
March 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04345328
Start Date
March 23 2017
End Date
September 1 2021
Last Update
September 20 2021
Active Locations (1)
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1
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000