An interventional study of Ileal Interposition and Traditional surgical technique in Obesity, sponsored by Rio de Janeiro State University. Recruiting at 1 site in Brazil. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Rio de Janeiro State University · Not applicable, Interventional, and Treatment
The investigators will study the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones
This prospective, controlled, randomized intervention study will investigate the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, health-related quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones. The participants will also be assessed for alcohol abuse, depressive symptoms, level of physical activity, eating disorder symptoms, and dumping syndrome.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Rio de Janeiro State University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Interposition ileal surgery group Procedure/Surgery: Bariatric surgery
Procedure: Ileal Interposition
Conventional revisional surgery group Procedure/Surgery: Bariatric surgery
Procedure: Traditional surgical technique
Bariatric surgery by laparoscopic Ileal Interposition
Bariatric surgery by laparoscopic traditional technique
Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms
Weight loss will be obtained as the difference between preoperative weight and minimum postoperative weight in kilograms
Time frame: Change from baseline and after 6 months post-surgery
Changes of Health-related quality of life of participants after Ileal interposition surgery as reported by 36-Item Short-Form Health Survey questionnaire
Health-related quality of life will be assessed using the 36-Item Short-Form Health Survey questionnaire
Time frame: Change from Baseline and after 6 months post-surgery
Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms
Weight loss will be obtained as the difference between preoperative weight and minimum
Time frame: Change from baseline and after 3, 6, and 12 months post-surgery
Change of body composition of participants after Ileal interposition surgery as measured by lean and fat mass in kilograms
Body composition will be assessed through dual X-ray absorptiometry (DXA)
Time frame: Change from baseline and after 6 and 12 months post-surgery
Change of metabolic profile of participants after Ileal interposition surgery as assessed by serum levels of glucose and insulin
Blood sample collection will include serum levels of glucose and insulin
Time frame: Change from baseline and after 6 and 12 months post-surgery
Change of inflammatory biomarkers and incretin hormones of participants after Ileal interposition surgery as assessed by serum levels of tumor necrosis factor-alpha, interleukin-6, ghrelin, and glucagon-like peptide-1.
Blood sample collection will include serum levels of tumor necrosis factor-alpha, interleukin-6, ghrelin, and glucagon-like peptide-1.
Time frame: Change from baseline and after 6 months post-surgery
Changes in alcohol abuse of participants after Ileal interposition surgery as reported by Alcohol Use Disorders Identification Test
Alcohol abuse will be assessed using the Alcohol Use Disorders Identification Test
Time frame: Change from baseline and after 6 and 12 months post-surgery
Changes in depressive symptoms of participants after Ileal interposition surgery as reported by Beck Depression Inventory
Depressive symptoms will be assessed using the Beck Depression Inventory questionnaire
Time frame: Change from baseline and after 6 and 12 months post-surgery
Changes in the level of physical activity of participants after Ileal interposition surgery as reported by the International Physical Activity Questionnaire
Levels of physical activity will be assessed using the International Physical Activity Questionnaire
Time frame: Change from baseline and after 6 and 12 months post-surgery
Changes in the eating disorder symptoms of participants after Ileal interposition surgery as reported by the Eating Disorder Examination Questionnaire
Eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire
Time frame: Change from baseline and after 6 and 12 months post-surgery
Plan to share: No
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Rio de Janeiro State University