ObesityPhase 3NCT02183935

Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

A Phase 3 study testing Duodena-jejunal liner in people with Obesity and Diabetes, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 20 years
Conditions the study is for: Obesity, Diabetes, Metabolic Syndrome
What is being tested?: Duodena-jejunal liner
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteSlovenia
Study dates: Jul 2014to 20 Dec 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

UMC Ljubljana
Ljubljana

Other trials in Slovenia

About this study

Official title: Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner - a Study on Efficacy and Pathophysiologic Mechanisms

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.

Conditions: Obesity, Diabetes, Metabolic Syndrome
Being tested: Duodena-jejunal liner
Keywords: Obesity, Diabetes, Metabolic syndrome, Gut hormones, Adipokines, Appetite, Adolescent
Medical subject headings: Obesity, Diabetes Mellitus, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duodena-jejunal linerDevice
Also called Endobarrier

Study groups in NCT02183935
Study group	Role	What they receive
Lifestyle counseling, metformin	No intervention	Age, gender and BMI matched controls will be managed by lifestyle counseling and metformin if indicated.
Duodeno - jejunal liner	Active comparator	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. Receives: Device: Duodena-jejunal liner

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in BMI (BMI SDS)
Measured: 12 and 24 months

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201420 Dec 2018

First posted8 Jul 2014 (estimated)
Study startJul 2014
Primary completion10 Dec 2018
Study completion20 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02183935
Sponsor's protocol ID: EB-AD-39/03/14
Status last verified: Jul 2020
First submitted: 30 Jun 2014
Last updated: 10 Jul 2020
Results posted: No
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner - a Study on Efficacy and Pathophysiologic Mechanisms
ClinicalTrials.gov ID: NCT02183935
Acronym / sponsor ID: EB-AD-39/03/14
Conditions: Obesity, Diabetes, Metabolic Syndrome
Keywords: Obesity, Diabetes, Metabolic syndrome, Gut hormones, Adipokines, Appetite, Adolescent
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University Medical Centre LjubljanaUniversity, hospital or other
Study start: Jul 2014
Primary completion: 10 Dec 2018 (actual)
Study completion: 20 Dec 2018 (actual)
First posted: 8 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lifestyle counseling, metformin	No intervention	–Age, gender and BMI matched controls will be managed by lifestyle counseling and metformin if indicated.
Duodeno - jejunal liner	Active comparator	Device: Duodena-jejunal linerDuodeno-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.

Who may qualify

Ages: 16 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Duodena-jejunal linerAlso: Endobarrier	Device	Duodeno - jejunal liner

Primary outcome

Change in BMI (BMI SDS)
Time frame: 12 and 24 months

6 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
Background: PubMed 22534421Escalona 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.
Background: PubMed 21932999de 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.
Background: PubMed 21442376de 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.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tadej Battelino, MD, PhD principal investigator

UMC Ljubljana

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duodena-jejunal liner in people with Obesity and Diabetes, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BMI (BMI SDS) (time frame: 12 and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02183935, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.