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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Limburg
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Maastricht, Limburg, 네덜란드, 6229 HX
- Maastricht University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Excess Weight (%)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Insulin levels (mmol/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Total Cholesterol (mmol/L)
기간: 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
기간: 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)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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ASAT (U/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Amylase (U/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Systolic blood pressure (mmHg)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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BMI (Kg/M2)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Diastolic blood pressure (mmHg)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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glucose levels (mmol/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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HbA1c level (%)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Triglycerides (mmol/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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HDL (mmol/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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LDL (mmol/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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L-FABP (ng/ml)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Lipase (U/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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ALAT (U/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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AF (U/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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GammaGT (U/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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Albumin (g/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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CK-18 (U/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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C-peptide (nmol/L)
기간: 36 months post explant EndoBarrier Liner
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36 months post explant EndoBarrier Liner
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nicole Bouvy, MD, PhD, Maastricht University Medical Center, The Netherlands
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NL51074.068.14
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
EndoBarrier에 대한 임상 시험
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Universitätsklinikum Hamburg-EppendorfGI Dynamics알려지지 않은
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Imperial College LondonUniversity Hospital Southampton NHS Foundation Trust; National Institute for Health Research... 그리고 다른 협력자들알려지지 않은
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The Mediterranean Institute for Transplantation...알려지지 않은