Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-02 @ 1:27 PM
Study NCT ID:
NCT02183935
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner
Sponsor:
University Medical Centre Ljubljana
Organization:
Study Overview
Official Title:
Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner - a Study on Efficacy and Pathophysiologic Mechanisms
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: