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Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

Primary Purpose

Obesity, Diabetes, Metabolic Syndrome

Status
Completed
Phase
Phase 3
Locations
Slovenia
Study Type
Interventional
Intervention
Duodena-jejunal liner
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Diabetes, Metabolic syndrome, Gut hormones, Adipokines, Appetite, Adolescent

Eligibility Criteria

16 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMC Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Lifestyle counseling, metformin

Duodeno - jejunal liner

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in BMI (BMI SDS)

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2014
Last Updated
July 8, 2020
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT02183935
Brief Title
Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner
Official Title
Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner - a Study on Efficacy and Pathophysiologic Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes, Metabolic Syndrome
Keywords
Obesity, Diabetes, Metabolic syndrome, Gut hormones, Adipokines, Appetite, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling, metformin
Arm Type
No Intervention
Arm Description
Age, gender and BMI matched controls will be managed by lifestyle counseling and metformin if indicated.
Arm Title
Duodeno - jejunal liner
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Duodena-jejunal liner
Other Intervention Name(s)
Endobarrier
Primary Outcome Measure Information:
Title
Change in BMI (BMI SDS)
Time Frame
12 and 24 months
Secondary Outcome Measure Information:
Title
Change in basal and stimulated glucose and insulin levels
Time Frame
12 and 24 months
Title
Change in cholesterol levels
Time Frame
12 and 24 months
Title
Change in selected gut hormones
Time Frame
12 and 24 months
Title
Change in selected adipokine and inflammatory cytokines levels
Time Frame
12 and 24 months
Title
Change in activity of selected appetite-associated central nervous system regions.
Time Frame
12 and 24 months
Title
Change in emotional and behaviour problems, body image and eating disorder symptoms
Time Frame
12 and 24 months
Other Pre-specified Outcome Measures:
Title
Safety profile of DJL in adolescents.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadej Battelino, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22534421
Citation
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.
Results Reference
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PubMed Identifier
21932999
Citation
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.
Results Reference
background
PubMed Identifier
21442376
Citation
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.
Results Reference
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Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

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