Impact of Bariatric Surgery on the Gut Environment (IMPORTUNE)
Impact of the Bacterial Colonial Metabolism on Fecal Water Toxicity as Biomarkers of Future Colorectal Cancer Risk After Bariatric Surgery
調査の概要
状態
条件
詳細な説明
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-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 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 3 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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Vlaams-Brabant
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Leuven、Vlaams-Brabant、ベルギー、3000
- University Hospital Leuven
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
- 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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Roux-en-Y gastric bypass
Patients who were planned for surgery with Roux-en-Y gastric bypass and were operated
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Sleeve Gastrectomy
Patients who were planned for surgery with Sleeve Gastrectomy and were operated
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Control group
Obese patients involved in a weight loss program that focuses on diet and lifestyle changes
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery
時間枠：Baseline and 2 weeks, 3 months, 6 months and 1 year after surgery
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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.
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Baseline and 2 weeks, 3 months, 6 months and 1 year after surgery
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Degree of protein assimilation 6-24 months after bariatric surgery
時間枠：6-24 months after surgery
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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.
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6-24 months after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Degree of fat malabsorption 6-24 months after bariatric surgery
時間枠：6-24 months after surgery
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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.
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6-24 months after surgery
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Kristin Verbeke, PhD、KU Leuven
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- s59836
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。