The EndoBarrier Device: A 3-year Follow up Study
The Effect of the EndoBarrier Device: A 3-year Follow up of a Randomized Clinical Trial
調査の概要
詳細な説明
In this observational follow-up study of a randomised clinical trial a maximum of 29 study participants may be included. These study participants were previously enrolled in the EndoBarrier device study at the MUMC or the Atrium Medical Centre Heerlen. The focus of this study lays on the long-term outcomes measured by EWL, postoperative blood sampling and questionnaires. These measurements, samples and questionnaires will be taken to assess the long-term effectiveness of the EndoBarrier device in the treatment of morbid obesity. Participants who were previously enrolled in the EndoBarrier device study at the MUMC or at the Atrium Medical Centre in Heerlen and who have agreed to participate in this study will be requested to arrive at the outpatient clinic of the MUMC after an overnight fast. Blood sample will be taken for total cholesterol, HDL, LDL, triglycerides, Hb, Ht, iron, HbA1c, insulin levels, glucose, amylase, lipase, C-peptide, Creatinine, vitamin D, Calcium, ALAT, ASAT, AF, gamma GT, albumin, CK-18, L-FABP, FGF19, Total bile salts and bile salt composition. These parameters are associated with risk factors in morbid obesity namely: Nonalcoholic Fatty Liver disease, hypertension, diabetes mellitus type II (DMII), coronary heart disease and osteoarthritis. After the blood sampling, physical health will be assessed by means of standard physical examination (weight, waist size, length, blood pressure, heart rate, breathing frequency). Then, the participant will be requested to fill in a validated questionnaire. In this study the SF-36 quality of life questionnaire will be used. This is a validated questionnaire assessing non-specific symptoms and quality of life after Bariatric surgery.
Three years of follow-up after the EndoBarrier device is now available. The investigators hope to give new insights in the postoperative status and postoperative symptoms experienced by participants using standardised questionnaires and evaluating blood samples. The goal of the investigators is to study the long-term effect of the EndoBarrier procedure and to possibly provide insight in the relation between success/failure and objective parameters.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Limburg
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Maastricht、Limburg、オランダ、6229 HX
- Maastricht University Medical Center
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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
説明
Inclusion Criteria:
- Participants who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC and the Atrium Medical Centre Heerlen regardless of their excess weight loss.
- Participants who have a follow up of at least 3 years.
- Signed informed consent.
Exclusion Criteria:
- Post-EndoBarrier conventional bariatric surgery
- Participants who were lost to follow-up during the previous conducted EndoBarrier clinical trial.
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 |
介入・治療 |
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EndoBarrier
Participants who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC and the Atrium Medical Centre Heerlen.
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The device is a 60-cm long, impermeable plastic sleeve that is open at both sides so food can pass through.
The sleeve is anchored in the duodenal bulb and extends partially into the jejunum.
This way the pancreatic and bile juices will only mix with the food after the sleeve, hereby creating a functional bypass of the duodenum and the proximal jejunum, which causes malabsorption of nutrients.
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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 |
時間枠 |
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Excess Weight (%)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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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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Insulin levels (mmol/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Total Cholesterol (mmol/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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SF-36 health related quality of life, patient-reported survey of patient health
時間枠：36 months post explant EndoBarrier Liner
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The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
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36 months post explant EndoBarrier Liner
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FGF 19 (ng/ml)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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ASAT (U/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Amylase (U/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Systolic blood pressure (mmHg)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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BMI (Kg/M2)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Diastolic blood pressure (mmHg)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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glucose levels (mmol/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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HbA1c level (%)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Triglycerides (mmol/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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HDL (mmol/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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LDL (mmol/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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L-FABP (ng/ml)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Lipase (U/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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ALAT (U/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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AF (U/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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GammaGT (U/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Albumin (g/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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CK-18 (U/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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C-peptide (nmol/L)
時間枠：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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協力者と研究者
捜査官
- 主任研究者：Nicole Bouvy, MD, PhD、Maastricht University Medical Center, The Netherlands
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
その他の研究ID番号
- NL51074.068.14
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。
EndoBarrierの臨床試験
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Imperial College LondonUniversity Hospital Southampton NHS Foundation Trust; National Institute for Health Research... と他の協力者わからない
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Sandwell & West Birmingham Hospitals NHS TrustAssociation of British Clinical Diabetologistsわからない