The EndoBarrier Device: A 3-year Follow up Study

Study Overview
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Brief Summary
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The aim in the current proposal is to evaluate the long-term outcome of the EndoBarrier device. The group of participants the investigators want to study participated in earlier studies at the Maastricht University Medical Center (MUMC) and the Atrium Medical Center in Heerlen. 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 the study 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.

Detailed Description
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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.

Official Title
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The Effect of the EndoBarrier Device: A 3-year Follow up of a Randomized Clinical Trial

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Device: EndoBarrier


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EndoBarrier<br>Participants who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC and the Atrium Medical Centre Heerlen. | Device: EndoBarrier<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess Weight (%) |  | 36 months post explant EndoBarrier Liner | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin levels (mmol/L) |  | 36 months post explant EndoBarrier Liner | 
| Total Cholesterol (mmol/L) |  | 36 months post explant EndoBarrier Liner | 
| SF-36 health related quality of life, patient-reported survey of patient health | 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. | 36 months post explant EndoBarrier Liner | 
| FGF 19 (ng/ml) |  | 36 months post explant EndoBarrier Liner | 
| ASAT (U/L) |  | 36 months post explant EndoBarrier Liner | 
| Amylase (U/L) |  | 36 months post explant EndoBarrier Liner | 
| Systolic blood pressure (mmHg) |  | 36 months post explant EndoBarrier Liner | 
| BMI (Kg/M2) |  | 36 months post explant EndoBarrier Liner | 
| Diastolic blood pressure (mmHg) |  | 36 months post explant EndoBarrier Liner | 
| glucose levels (mmol/L) |  | 36 months post explant EndoBarrier Liner | 
| HbA1c level (%) |  | 36 months post explant EndoBarrier Liner | 
| Triglycerides (mmol/L) |  | 36 months post explant EndoBarrier Liner | 
| HDL (mmol/L) |  | 36 months post explant EndoBarrier Liner | 
| LDL (mmol/L) |  | 36 months post explant EndoBarrier Liner | 
| L-FABP (ng/ml) |  | 36 months post explant EndoBarrier Liner | 
| Lipase (U/L) |  | 36 months post explant EndoBarrier Liner | 
| ALAT (U/L) |  | 36 months post explant EndoBarrier Liner | 
| AF (U/L) |  | 36 months post explant EndoBarrier Liner | 
| GammaGT (U/L) |  | 36 months post explant EndoBarrier Liner | 
| Albumin (g/L) |  | 36 months post explant EndoBarrier Liner | 
| CK-18 (U/L) |  | 36 months post explant EndoBarrier Liner | 
| C-peptide (nmol/L) |  | 36 months post explant EndoBarrier Liner | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EndoBarrier, Duodenojejunal Bypass Liner