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Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02183935
Recruitment Status : Unknown
Verified July 2014 by Tadej Battelino, University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Tadej Battelino, University Medical Centre Ljubljana

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Metabolic Syndrome Device: Duodena-jejunal liner Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner - a Study on Efficacy and Pathophysiologic Mechanisms
Study Start Date : July 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
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
Other Name: Endobarrier




Primary Outcome Measures :
  1. Change in BMI (BMI SDS) [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures :
  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 ]

Other Outcome Measures:
  1. Safety profile of DJL in adolescents. [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   16 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183935


Contacts
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Contact: Tadej Battelino, MD, PhD 00386 1 522 9235 tadej.battelino@mf.uni-lj.si

Locations
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Slovenia
UMC Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Tadej Battelino, PhD    00386 01 522 9235    tadej.battelino@mf.uni-lj.si   
Principal Investigator: Tadej Battelino, MD, PhD         
Sub-Investigator: Rok Orel, MD, PhD         
Sub-Investigator: Matjaž Homan, MD, PhD         
Sub-Investigator: Primož Kotnik, MD, PhD         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Tadej Battelino, MD, PhD UMC Ljubljana

Publications:
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Responsible Party: Tadej Battelino, Prof. Dr., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02183935    
Other Study ID Numbers: EB-AD-39/03/14
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by Tadej Battelino, University Medical Centre Ljubljana:
Obesity
Diabetes
Metabolic syndrome
Gut hormones
Adipokines
Appetite
Adolescent
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases