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
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Limburg
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Maastricht、Limburg、荷兰、6229 HX
- Maastricht University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Excess Weight (%)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Insulin levels (mmol/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Total Cholesterol (mmol/L)
大体时间：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
大体时间：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)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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ASAT (U/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Amylase (U/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Systolic blood pressure (mmHg)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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BMI (Kg/M2)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Diastolic blood pressure (mmHg)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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glucose levels (mmol/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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HbA1c level (%)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Triglycerides (mmol/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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HDL (mmol/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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LDL (mmol/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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L-FABP (ng/ml)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Lipase (U/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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ALAT (U/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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AF (U/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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GammaGT (U/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Albumin (g/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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CK-18 (U/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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C-peptide (nmol/L)
大体时间：36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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合作者和调查者
调查人员
- 首席研究员：Nicole Bouvy, MD, PhD、Maastricht University Medical Center, The Netherlands
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NL51074.068.14
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
EndoBarrier的临床试验
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Universitätsklinikum Hamburg-EppendorfGI Dynamics未知
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Imperial College LondonUniversity Hospital Southampton NHS Foundation Trust; National Institute for Health Research... 和其他合作者未知