The EndoBarrier Device: A 3-year Follow up Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566330
• Other study ID #: NL51074.068.14
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2015
• Last updated: July 7, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess Weight (%)		36 months post explant EndoBarrier Liner	No
Secondary	Insulin levels (mmol/L)		36 months post explant EndoBarrier Liner	No
Secondary	Total Cholesterol (mmol/L)		36 months post explant EndoBarrier Liner	No
Secondary	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	No
Secondary	FGF 19 (ng/ml)		36 months post explant EndoBarrier Liner	No
Secondary	ASAT (U/L)		36 months post explant EndoBarrier Liner	No
Secondary	Amylase (U/L)		36 months post explant EndoBarrier Liner	No
Secondary	Systolic blood pressure (mmHg)		36 months post explant EndoBarrier Liner	No
Secondary	BMI (Kg/M2)		36 months post explant EndoBarrier Liner	No
Secondary	Diastolic blood pressure (mmHg)		36 months post explant EndoBarrier Liner	No
Secondary	glucose levels (mmol/L)		36 months post explant EndoBarrier Liner	No
Secondary	HbA1c level (%)		36 months post explant EndoBarrier Liner	No
Secondary	Triglycerides (mmol/L)		36 months post explant EndoBarrier Liner	No
Secondary	HDL (mmol/L)		36 months post explant EndoBarrier Liner	No
Secondary	LDL (mmol/L)		36 months post explant EndoBarrier Liner	No
Secondary	L-FABP (ng/ml)		36 months post explant EndoBarrier Liner	No
Secondary	Lipase (U/L)		36 months post explant EndoBarrier Liner	No
Secondary	ALAT (U/L)		36 months post explant EndoBarrier Liner	No
Secondary	AF (U/L)		36 months post explant EndoBarrier Liner	No
Secondary	GammaGT (U/L)		36 months post explant EndoBarrier Liner	No
Secondary	Albumin (g/L)		36 months post explant EndoBarrier Liner	No
Secondary	CK-18 (U/L)		36 months post explant EndoBarrier Liner	No
Secondary	C-peptide (nmol/L)		36 months post explant EndoBarrier Liner	No