Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02183935
• Date of registration: 30/06/2014
• Prospective Registration: Yes
• Primary sponsor: University Medical Centre Ljubljana
• Public title: Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner
• Scientific title: Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner - a Study on Efficacy and Pathophysiologic Mechanisms
• Date of first enrolment: July 2014
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02183935
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Slovenia

Contacts

• Name: Tadej Battelino, MD, PhD
• Affiliation: UMC Ljubljana

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects estimated to fully comply with study protocol and have signed an informed
consent form.

- Age > 15 years.

- BMI = 99. percentile for age and gender.

- Inefficient conservative measures (of at least 6 months duration) to decrease body
weight (characterized as a decrease in BMI > 10 %).

- Documented negative pregnancy test in women of childbearing potential.

- Women of childbearing potential agree to remain on contraceptives for the duration of
their trial participation.

Exclusion Criteria:

- Previous GI surgery that could potentially affect the ability to place sleeve or
affect the function of the implant.

- Subjects with congenital or acquired anomalies of the GI tract which in the opinion of
the investigator, may impair implantation of the EndoBarrier device.

- Subjects who had gastrooesophageal reflucs disease..

- Known abnormal pathologies or conditions of the gastrointestinal tract, including
ulcers or Crohn's disease, upper gastro-intestinal bleeding conditions.

- Coagulopathy defined as Hgb <10g/dl and platelet < 100,000/ml or diagnosis of other
severe coagulopathy like hemophilia.

- Any documented history of acute or chronic pancreatitis.

- Subjects requiring regular antithrombotic therapy (i.e. anticoagulant or antiplatelet
agent).

- Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune
connective tissue disorder.

- Subject is or has been enrolled in another investigational study within 6 months of
participation into the EndoBarrier study.

- Subjects who are mentally retarded or emotionally unstable.

- Subjects who are pregnant or were breastfeeding.

- Subjects with an abnormal laboratory or ECG abnormality which the investigators deems
clinically significant and makes the patient a poor candidate for the study.



Age minimum: 16 Years
Age maximum: 20 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Diabetes

Obesity

Intervention(s)

Device: Duodena-jejunal liner

Primary Outcome(s)

Change in BMI (BMI SDS) [Time Frame: 12 and 24 months]

Secondary Outcome(s)

Change in basal and stimulated glucose and insulin levels [Time Frame: 12 and 24 months]

Change in selected adipokine and inflammatory cytokines levels [Time Frame: 12 and 24 months]

Change in cholesterol levels [Time Frame: 12 and 24 months]

Change in emotional and behaviour problems, body image and eating disorder symptoms [Time Frame: 12 and 24 months]

Change in activity of selected appetite-associated central nervous system regions. [Time Frame: 12 and 24 months]

Change in selected gut hormones [Time Frame: 12 and 24 months]

Secondary ID(s)

EB-AD-39/03/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors