Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

Phase 3

Completed

• Conditions: Diabetes; Metabolic Syndrome; Obesity
• Interventions: Device: Duodena-jejunal liner

• Registration Number: NCT02183935
• Lead Sponsor: 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.

* To evaluate psychological outcomes; change in emotional and behaviour problems, in body image, in eating disorder symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-30
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Primary Completion: 2018-12-10
• Study Completion: 2018-12-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duodeno - jejunal liner	Duodena-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.

Primary Outcome Measures

Name	Time	Method
Change in BMI (BMI SDS)	12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Change in basal and stimulated glucose and insulin levels	12 and 24 months
Change in activity of selected appetite-associated central nervous system regions.	12 and 24 months
Change in selected adipokine and inflammatory cytokines levels	12 and 24 months
Change in cholesterol levels	12 and 24 months
Change in emotional and behaviour problems, body image and eating disorder symptoms	12 and 24 months
Change in selected gut hormones	12 and 24 months

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia