Laparoscopic Ileal Interposition and Weight Regain

Obesity Clinical Trial

Official title:

Ileal Interposition to the Treatment of Weight Regain After Roux-en-Y Gastric Bypass: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931939
• Other study ID #: Ileal interposition
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: Rio de Janeiro State University
• Contact: Luiz Guilherme G Kraemer-Aguiar, PhD
• Phone: +55 21 23340703
• Email: lgkraemeraguiar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients submitted to initial laparoscopic after initial Roux-en-Y gastric bypass for at least 3 years

• Loss of excess weight between 60 to 80%

• Rate of weight regain =60%

• Body mass index = 40 kg/m2 or = 35 kg/m2, with at least 2 comorbidities associated with obesity

• Present a previous evaluation by the multidisciplinary team with a favorable opinion of the revision surgery.

Exclusion Criteria:

• Active chemical dependency on alcohol and/or illicit drugs

• Severe psychotic or depressive disorder or history of suicide attempts in the last 12 months

• Eating behavior disorder (uncontrolled)

• Secondary causes of obesity

• Pregnancy

• Severe organ failure

• Active neoplastic

• Infectious or inflammatory disease

• Severe coagulopathy

• High anesthetic-surgical risk

• Intellectual inability

• Lack of preoperative follow-up

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Ileal Interposition
Bariatric surgery by laparoscopic Ileal Interposition
• Traditional surgical technique
Bariatric surgery by laparoscopic traditional technique

Locations

Country	Name	City	State
Brazil	State University of Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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)	Change from baseline and after 6 and 12 months post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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