Impact of Bariatric Surgery on the Gut Environment

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СъстояниеНабиране

Спонсори

KU Leuven

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT04345328

BioSeek: nct04345328

Ключови думи

Резюме

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, we will measure toxicity parameters to understand better the health status of their colon after surgery. In a next phase, we will link the measured toxicity 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, we will investigate the fate of ingested protein once the surgery patients are metabolically stabilized.

Описание

To quantify protein assimilation after bariatric surgery, we will perform in bariatric surgery patients (Roux-en- Y gastric bypass and Sleeve Gastrectomy) and in a control group a cross-sectional study with a single test day. On the test day, the study participants will consume a test meal that contains intrinsically labelled egg proteins and will take a capsule with 14C-glycocholic acid and a capsule with 3H-labelled polyethylene glycol. Participants will record a food diary 72h before and after the test day and during the test they will collect breath samples for 6h. Urine and stool will be collected respectively up to 24h and 72h after consumption of the test meal.

For the 1-year follow up study, the three patient groups (Roux-en-Y gastric bypass, Sleeve gastrectomy and control group with traditional weight loss therapy) will have 5 visits, a baseline visit and 4 visits after surgery or after starting traditional therapy. The time points after baseline include 2 weeks, 3 months, 6 months and 12 months. Each visit, a blood and stool sample will be collected, a 7-day food and stool diary will be registered and also weight loss will be recorded.

Дати

Последна проверка:	03/31/2020
Първо изпратено:	04/09/2020
Очаквано записване подадено:	04/09/2020
Първо публикувано:	04/13/2020
Изпратена последна актуализация:	04/09/2020
Последна актуализация публикувана:	04/13/2020
Действителна начална дата на проучването:	03/22/2017
Приблизителна дата на първично завършване:	05/31/2021
Очаквана дата на завършване на проучването:	08/31/2021

Състояние или заболяване

Bariatric Surgery Candidate

Фаза

Групи за ръце

Arm	Интервенция / лечение
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

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Метод за вземане на проби	Probability Sample
Приема здрави доброволци	Не
Критерии	Inclusion Criteria: - 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 Criteria: - 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.

Резултат

Първични изходни мерки

1. Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery [Baseline and 2 weeks, 3 months, 6 months and 1 year after surgery]

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

2. Degree of protein assimilation 6-24 months after bariatric surgery [6-24 months after surgery]

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

Вторични изходни мерки

1. Degree of fat malabsorption 6-24 months after bariatric surgery [6-24 months after surgery]

Malabsorption of fat : calculated as ((fat intake- fat excretion)/fat intake)*100%, expressed as coefficient of fat absorption. Excretion : measured with the Van de Kamer method.