ObesityNCT05931939
Laparoscopic Ileal Interposition and Weight Regain
A study testing Ileal Interposition and Traditional surgical technique in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
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 Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Ileal Interposition and Traditional surgical technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- Active neoplastic
- Infectious or inflammatory disease
- Severe coagulopathy
- High anesthetic-surgical risk
- Intellectual inability
- Lack of preoperative follow-up
Trial locations and contacts
1 site in 1 country.
Karynne Grutter Lopes, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
State University of Rio de Janeiro
Rio de Janeiro
Luiz Guilherme Kraemer-Aguiar, PhD, 55212868-8212
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- Ileal Interposition, Traditional surgical technique
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileal InterpositionProcedure or surgery
Bariatric surgery by laparoscopic Ileal Interposition
Traditional surgical techniqueProcedure or surgery
Bariatric surgery by laparoscopic traditional technique
| Study group | Role | What they receive |
|---|---|---|
| Ileal Interposition | Experimental | Interposition ileal surgery group Procedure/Surgery: Bariatric surgery Receives: Procedure: Ileal Interposition |
| Traditional surgical technique | Active comparator | Conventional revisional surgery group Procedure/Surgery: Bariatric surgery Receives: Procedure: Traditional surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from Baseline and after 6 months post-surgery
Secondary outcomes (8)
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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline and after 6 and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Dec 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University
- Investigators
- Luiz Guilherme Kraemer-Aguiar, PhD, Principal investigator, State University of Rio de JaneiroPaulo Roberto G Falcão Leal, MD, Principal investigator, State University of Rio de JaneiroKarynne G Grutter Lopes, PhD, Principal investigator, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931939
- Sponsor's protocol ID
- Ileal interposition
- Status last verified
- Apr 2024
- First submitted
- 7 May 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ileal Interposition to the Treatment of Weight Regain After Roux-en-Y Gastric Bypass: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05931939
- Acronym / sponsor ID
- Ileal interposition
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, controlled, randomized intervention study, comparing the effect of revisional surgery by laparoscopic Ileal Interposition with traditional surgical technique
| Arm | Type | Receives |
|---|---|---|
| Ileal Interposition | Experimental | Procedure: Ileal InterpositionInterposition ileal surgery group Procedure/Surgery: Bariatric surgery |
| Traditional surgical technique | Active comparator | Procedure: Traditional surgical techniqueConventional revisional surgery group Procedure/Surgery: Bariatric surgery |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ileal InterpositionBariatric surgery by laparoscopic Ileal Interposition | Procedure or surgery | Ileal Interposition |
| Traditional surgical techniqueBariatric surgery by laparoscopic traditional technique | Procedure or surgery | Traditional surgical technique |
Primary outcome
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
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karynne Grutter Lopes, PhD contact
Luiz Guilherme Kraemer-Aguiar, PhD principal investigator
State University of Rio de Janeiro
Paulo Roberto G Falcão Leal, MD principal investigator
State University of Rio de Janeiro
Karynne G Grutter Lopes, PhD principal investigator
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileal Interposition and Traditional surgical technique in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz Guilherme G Kraemer-Aguiar, PhD (+55 21 23340703, lgkraemeraguiar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.