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CompletedNCT02183935Updated Jul 10, 2020

Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

A Phase 3 interventional study of Duodena-jejunal liner in Obesity, Diabetes and Metabolic Syndrome, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 16 Years to 20 Years. Per ClinicalTrials.gov, last updated 2020-07-10.

Sponsored by University Medical Centre Ljubljana · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
16 Years to 20 Years
Sex
All
01

Study summary

Obesity and its complications have a significant effect on morbidity and mortality in these subjects. Especially at risk are subjects with extremely increased BMI (above 99th percentile for age and gender in adolescents). In these subjects classical treatment with diet and cognitive therapy has a limited effect. Bariatric procedures, at the moment, are the only feasible therapeutic possibility.

Bariatric procedures are based on several principles; restrictive, malabsorptive and combined. They can be surgical or endoscopic. The later are used in subjects that do not qualify for surgical procedures that decline them or are used before a planed definite bariatric procedure.

Duodena-jejunal liner (DJL) is an endoscopic tool, that is efficiently and safely used to decrease body weight and ameliorated obesity complications, especially those associated with diabetic state.

Aims of the study are:

  • To determine (short and long-term) efficacy of DJL in decreasing body weight in adolescents.
  • To determine (short and long-term) efficacy of DJL in ameliorating complications of morbid obesity - abnormal glucose metabolism, dislipidemia, altered adipokine secretion pattern, altered secretion pattern of gastrointestinal hormones in adolescents.
  • To visualize functional alternations in the selected central nervous system regions associated with appetite regulation upon insertion of DJL.
  • To evaluate psychological outcomes; change in emotional and behaviour problems, in body image, in eating disorder symptoms.
02

Conditions studied

  • Obesity
  • Diabetes
  • Metabolic Syndrome

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Keywords

  • Obesity
  • Diabetes
  • Metabolic syndrome
  • Gut hormones
  • Adipokines
  • Appetite
  • Adolescent
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 22 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • No intervention
    Lifestyle counseling, metformin

    Age, gender and BMI matched controls will be managed by lifestyle counseling and metformin if indicated.

  • Active comparator
    Duodeno - jejunal liner

    Duodeno-jejunal liner (Endobarrier) will be implanted for the duration of 12 months. During this time subjects will be regularly monitored for investigated parameters. In addition, subjects will be carefully monitored upon device removal for additional 12 months.

    Device: Duodena-jejunal liner

Interventions

  • DeviceDuodena-jejunal liner

    Also known as: Endobarrier

06

What researchers measure

Primary outcomes

  1. Change in BMI (BMI SDS)

    Time frame: 12 and 24 months

Secondary outcomes

  1. Change in basal and stimulated glucose and insulin levels

    Time frame: 12 and 24 months

  2. Change in cholesterol levels

    Time frame: 12 and 24 months

  3. Change in selected gut hormones

    Time frame: 12 and 24 months

  4. Change in selected adipokine and inflammatory cytokines levels

    Time frame: 12 and 24 months

  5. Change in activity of selected appetite-associated central nervous system regions.

    Time frame: 12 and 24 months

  6. Change in emotional and behaviour problems, body image and eating disorder symptoms

    Time frame: 12 and 24 months

Other outcomes

  1. Safety profile of DJL in adolescents.

    Number of participants with adverse events (pain, nausea, vomiting, bleeding, gastrointestinal obstruction) and number of adverse events will be used to measure safety and tolerability of the investigated device in adolescents.

    Time frame: 12 months

07

Study locations

1 site
  • UMC Ljubljana
    Ljubljana, Slovenia
08

References and documents

Publications

  • Escalona A, Pimentel F, Sharp A, Becerra P, Slako M, Turiel D, Munoz R, Bambs C, Guzman S, Ibanez L, Gersin K. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. Ann Surg. 2012 Jun;255(6):1080-5. doi: 10.1097/SLA.0b013e31825498c4. PubMed 22534421 ↗
  • de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20. PubMed 21932999 ↗
  • de Moura EG, Orso IR, Martins BC, Lopes GS, de Oliveira SL, Galvao-Neto Mdos P, Mancini MC, Santo MA, Sakai P, Ramos AC, Garrido-Junior AB, Halpern A, Cecconello I. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg. 2011 Jul;21(7):941-7. doi: 10.1007/s11695-011-0387-0. PubMed 21442376 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02183935
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Tadej Battelino (Prof. Dr., University Medical Centre Ljubljana) — Principal investigator
First posted
Jul 8, 2014
Start date
Jul 2014
Primary completion
Dec 10, 2018
Completion
Dec 20, 2018
Last update
Jul 10, 2020

Study contacts

Tadej Battelino, MD, PhD
principal investigator · UMC Ljubljana

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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