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Completed

NCT Number: NCT02566330

The EndoBarrier Device: A 3-year Follow up Study

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.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EndoBarrier

Device

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.

Primary outcomes

  1. Excess Weight (%)

    Time frame: 36 months post explant EndoBarrier Liner

Secondary outcomes

  1. Insulin levels (mmol/L)

    Time frame: 36 months post explant EndoBarrier Liner

  2. Total Cholesterol (mmol/L)

    Time frame: 36 months post explant EndoBarrier Liner

  3. SF-36 health related quality of life, patient-reported survey of patient health

    Time frame: 36 months post explant EndoBarrier Liner

    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.

  4. FGF 19 (ng/ml)

    Time frame: 36 months post explant EndoBarrier Liner

  5. ASAT (U/L)

    Time frame: 36 months post explant EndoBarrier Liner

  6. Amylase (U/L)

    Time frame: 36 months post explant EndoBarrier Liner

  7. Systolic blood pressure (mmHg)

    Time frame: 36 months post explant EndoBarrier Liner

  8. BMI (Kg/M2)

    Time frame: 36 months post explant EndoBarrier Liner

  9. Diastolic blood pressure (mmHg)

    Time frame: 36 months post explant EndoBarrier Liner

  10. glucose levels (mmol/L)

    Time frame: 36 months post explant EndoBarrier Liner

  11. HbA1c level (%)

    Time frame: 36 months post explant EndoBarrier Liner

  12. Triglycerides (mmol/L)

    Time frame: 36 months post explant EndoBarrier Liner

  13. HDL (mmol/L)

    Time frame: 36 months post explant EndoBarrier Liner

  14. LDL (mmol/L)

    Time frame: 36 months post explant EndoBarrier Liner

  15. L-FABP (ng/ml)

    Time frame: 36 months post explant EndoBarrier Liner

  16. Lipase (U/L)

    Time frame: 36 months post explant EndoBarrier Liner

  17. ALAT (U/L)

    Time frame: 36 months post explant EndoBarrier Liner

  18. AF (U/L)

    Time frame: 36 months post explant EndoBarrier Liner

  19. GammaGT (U/L)

    Time frame: 36 months post explant EndoBarrier Liner

  20. Albumin (g/L)

    Time frame: 36 months post explant EndoBarrier Liner

  21. CK-18 (U/L)

    Time frame: 36 months post explant EndoBarrier Liner

  22. C-peptide (nmol/L)

    Time frame: 36 months post explant EndoBarrier Liner

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2015
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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