Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Change in BMI (BMI SDS) [ Time Frame: 12 and 24 months ]
- Change in basal and stimulated glucose and insulin levels [ Time Frame: 12 and 24 months ]
- Change in cholesterol levels [ Time Frame: 12 and 24 months ]
- Change in selected gut hormones [ Time Frame: 12 and 24 months ]
- Change in selected adipokine and inflammatory cytokines levels [ Time Frame: 12 and 24 months ]
- Change in activity of selected appetite-associated central nervous system regions. [ Time Frame: 12 and 24 months ]
- 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.
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
|Contact: Tadej Battelino, MD, PhD||00386 1 522 firstname.lastname@example.org|
|Contact: Tadej Battelino, PhD 00386 01 522 9235 email@example.com|
|Principal Investigator: Tadej Battelino, MD, PhD|
|Sub-Investigator: Rok Orel, MD, PhD|
|Sub-Investigator: Matjaž Homan, MD, PhD|
|Sub-Investigator: Primož Kotnik, MD, PhD|
|Principal Investigator:||Tadej Battelino, MD, PhD||UMC Ljubljana|