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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duodena-jejunal liner | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI (BMI SDS) | 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of DJL in adolescents. | 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. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tadej Battelino, MD, PhD | UMC Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana | Ljubljana | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22534421 | Background | 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. | |
| 21932999 | Background |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Change in emotional and behaviour problems, body image and eating disorder symptoms | 12 and 24 months |
| 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. |
| 21442376 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |