Laparoscopic Ileal Interposition and Weight Regain

April 14, 2024 updated by: Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Recruiting
        • State University of Rio de Janeiro
        • Contact:
          • Luiz Guilherme Kraemer-Aguiar, PhD
          • Phone Number: 55212868-8212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ileal Interposition
Interposition ileal surgery group Procedure/Surgery: Bariatric surgery
Procedure: Ileal Interposition
Bariatric surgery by laparoscopic Ileal Interposition
Active Comparator: Traditional surgical technique
Conventional revisional surgery group Procedure/Surgery: Bariatric surgery
Procedure: Traditional surgical technique
Bariatric surgery by laparoscopic traditional technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms
Time Frame: Change from baseline and after 6 months post-surgery
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
Time Frame: Change from Baseline and after 6 months post-surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms
Time Frame: Change from baseline and after 3, 6, and 12 months post-surgery
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
Time Frame: Change from baseline and after 6 and 12 months post-surgery
Body composition will be assessed through dual X-ray absorptiometry (DXA)
Change from baseline and after 6 and 12 months post-surgery
Changes in alcohol abuse of participants after Ileal interposition surgery as reported by Alcohol Use Disorders Identification Test
Time Frame: Change from baseline and after 6 and 12 months post-surgery
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
Time Frame: Change from baseline and after 6 and 12 months post-surgery
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
Time Frame: Change from baseline and after 6 and 12 months post-surgery
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
Time Frame: Change from baseline and after 6 and 12 months post-surgery
Eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire
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
Time Frame: Change from baseline and after 6 and 12 months post-surgery
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.
Time Frame: Change from baseline and after 6 months post-surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rio de Janeiro State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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: Karynne G Grutter Lopes, PhD, State University of Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ileal interposition

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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