Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner

NCT02183935 | Completed Phase 3

• 1 other identifier: EB-AD-39/03/14
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes; Metabolic Syndrome

Keywords

Obesity; Diabetes; Metabolic syndrome; Gut hormones; Adipokines; Appetite; Adolescent

Outcome Measures

Primary Outcomes (1)

• Change in BMI (BMI SDS)

  12 and 24 months

Secondary Outcomes (6)

• Change in basal and stimulated glucose and insulin levels

  12 and 24 months

• Change in cholesterol levels

  12 and 24 months

• Change in selected gut hormones

  12 and 24 months

• Change in selected adipokine and inflammatory cytokines levels

  12 and 24 months

• Change in activity of selected appetite-associated central nervous system regions.

  12 and 24 months

Other Outcomes (1)

• Safety profile of DJL in adolescents.

  12 months

Study Arms (2)

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.

Device: Duodena-jejunal liner

Interventions

Duodena-jejunal liner DEVICE

Also known as: Endobarrier

Duodeno - jejunal liner

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 22534421 BACKGROUND

• 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.

  PMID: 21932999 BACKGROUND

• 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.

  PMID: 21442376 BACKGROUND

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Tadej Battelino, MD, PhD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2014
• Primary Completion: December 10, 2018
• Study Completion: December 20, 2018
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

SL (1)