Clinical trial NCT02566330: The EndoBarrier Device: A 3-year Follow up Study
Official title: The Effect of the EndoBarrier Device: A 3-year Follow up of a Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes
Keywords: EndoBarrier
Duodenojejunal Bypass Liner
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this observational follow-up study of a randomized clinical trial a maximum of 29 participants may be included who were previously enrolled in the EndoBarrier device study at the MUMC or the Atrium Medical Centre Heerlen.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Excess Weight (%)
timeFrame: 36 months post explant EndoBarrier Liner
Secondary outcomes:
measure: Insulin levels (mmol/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: Total Cholesterol (mmol/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: SF-36 health related quality of life, patient-reported survey of patient health
timeFrame: 36 months post explant EndoBarrier Liner
measure: FGF 19 (ng/ml)
timeFrame: 36 months post explant EndoBarrier Liner
measure: ASAT (U/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: Amylase (U/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: Systolic blood pressure (mmHg)
timeFrame: 36 months post explant EndoBarrier Liner
measure: BMI (Kg/M2)
timeFrame: 36 months post explant EndoBarrier Liner
measure: Diastolic blood pressure (mmHg)
timeFrame: 36 months post explant EndoBarrier Liner
measure: glucose levels (mmol/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: HbA1c level (%)
timeFrame: 36 months post explant EndoBarrier Liner
measure: Triglycerides (mmol/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: HDL (mmol/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: LDL (mmol/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: L-FABP (ng/ml)
timeFrame: 36 months post explant EndoBarrier Liner
measure: Lipase (U/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: ALAT (U/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: AF (U/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: GammaGT (U/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: Albumin (g/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: CK-18 (U/L)
timeFrame: 36 months post explant EndoBarrier Liner
measure: C-peptide (nmol/L)
timeFrame: 36 months post explant EndoBarrier Liner
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center, The Netherlands
name: Nicole Bouvy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: