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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ileal Interposition | Experimental | Interposition ileal surgery group Procedure/Surgery: Bariatric surgery |
|
| Traditional surgical technique | Active Comparator | Conventional revisional surgery group Procedure/Surgery: Bariatric surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ileal Interposition | Procedure | Bariatric surgery by laparoscopic Ileal Interposition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Change from Baseline and after 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiz Guilherme G Kraemer-Aguiar, PhD | Contact | +55 21 23340703 | lgkraemeraguiar@gmail.com | |
| Karynne Grutter Lopes, PhD | Contact | kjgolrj@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luiz Guilherme Kraemer-Aguiar, PhD | State University of Rio de Janeiro | Principal Investigator |
| Paulo Roberto G Falcão Leal, MD | State University of Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of Rio de Janeiro | Recruiting | Rio de Janeiro | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique
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| Traditional surgical technique | Procedure | Bariatric surgery by laparoscopic traditional technique |
|
Body composition will be assessed through dual X-ray absorptiometry (DXA) |
| 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 | 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. | 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 | 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 | 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 | 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 | Change from baseline and after 6 and 12 months post-surgery |
| Karynne G Grutter Lopes, PhD |
| State University of Rio de Janeiro |
| Principal Investigator |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |