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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Bariatric surgery by laparoscopic Ileal Interposition
Bariatric surgery by laparoscopic traditional technique
State University of Rio de Janeiro
Rio de Janeiro, Brazil
RECRUITINGChanges 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.
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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