The EndoBarrier Device: A 3-year Follow up Study
关键词
抽象
描述
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.
日期
| 最后验证: | 06/30/2016 |
| 首次提交: | 07/14/2015 |
| 提交的预估入学人数: | 09/30/2015 |
| 首次发布: | 10/01/2015 |
| 上次提交的更新: | 07/06/2016 |
| 最近更新发布: | 07/10/2016 |
| 实际学习开始日期: | 09/30/2015 |
| 预计主要完成日期: | 01/31/2016 |
| 预计完成日期: | 01/31/2016 |
状况或疾病
干预/治疗
Device: EndoBarrier
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| EndoBarrier Participants who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC and the Atrium Medical Centre Heerlen. | Device: EndoBarrier 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Excess Weight (%) [36 months post explant EndoBarrier Liner]
次要成果指标
1. Insulin levels (mmol/L) [36 months post explant EndoBarrier Liner]
2. Total Cholesterol (mmol/L) [36 months post explant EndoBarrier Liner]
3. SF-36 health related quality of life, patient-reported survey of patient health [36 months post explant EndoBarrier Liner]
4. FGF 19 (ng/ml) [36 months post explant EndoBarrier Liner]
5. ASAT (U/L) [36 months post explant EndoBarrier Liner]
6. Amylase (U/L) [36 months post explant EndoBarrier Liner]
7. Systolic blood pressure (mmHg) [36 months post explant EndoBarrier Liner]
8. BMI (Kg/M2) [36 months post explant EndoBarrier Liner]
9. Diastolic blood pressure (mmHg) [36 months post explant EndoBarrier Liner]
10. glucose levels (mmol/L) [36 months post explant EndoBarrier Liner]
11. HbA1c level (%) [36 months post explant EndoBarrier Liner]
12. Triglycerides (mmol/L) [36 months post explant EndoBarrier Liner]
13. HDL (mmol/L) [36 months post explant EndoBarrier Liner]
14. LDL (mmol/L) [36 months post explant EndoBarrier Liner]
15. L-FABP (ng/ml) [36 months post explant EndoBarrier Liner]
16. Lipase (U/L) [36 months post explant EndoBarrier Liner]
17. ALAT (U/L) [36 months post explant EndoBarrier Liner]
18. AF (U/L) [36 months post explant EndoBarrier Liner]
19. GammaGT (U/L) [36 months post explant EndoBarrier Liner]
20. Albumin (g/L) [36 months post explant EndoBarrier Liner]
21. CK-18 (U/L) [36 months post explant EndoBarrier Liner]
22. C-peptide (nmol/L) [36 months post explant EndoBarrier Liner]
