ObesityPLICATURENCT05750134
Endoscopic Sleeve Gastroplasty for Moderate Obesity
An observational study of Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Weight loss is of paramount importance to ameliorate obesity-related complications. Endoscopic sleeve gastroplasty is a new therapeutic option to obtain significant weight reduction in obese patients. Nevertheless, a only a part of patients experience sufficient weight loss to improve comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- OBPLUS Clinical Database : data analysis and Biological collection "Liver, bile ducts and pancreas": sample analysis
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2023to 31 Mar 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate obesity undergoing endoscopic sleeve gastroplasty
Who may be able to join
- Age ≥18 years
- Patients giving their consent for the study
- Body mass index between 28 and 35 kg/m2 with co-morbid condition (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, non-alcoholic fatty liver disease or invalidating joint pain)
- No weigh loss following life-style changes
Who cannot join
- Antibiotic treatment during the three previous months
- Patients at risk of gastric cancer requiring regular endoscopic surveillance
- Gastric localization of Crohn disease
- Portal hypertension
- Severe hepatic or renal failure
- Ongoing peptic ulcer
- Severe associated disease
- History of previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Antoine Béclère Hospital, Department of Hepatology, Gastroenterology, and Nutrition
Clamart, 92140
About this study
Official title: Endoscopic Sleeve Gastroplasty for Overweight or Moderately Obese Patients: Identification of Predictive Factors for Weight Loss
Weight loss is of paramount importance to ameliorate obesity-related complications. Endoscopic sleeve gastroplasty is a new therapeutic option to obtain significant weight reduction in obese patients. Nevertheless, a only a part of patients experience sufficient weight loss to improve comorbidities. A better understanding of mechanisms driving body weight trajectory after endoscopic sleeve gastroplasty may help patient selection and improve efficacy. The main aim of this study is to identify factors associated with weight reduction after endoscopic sleeve gastroplasty in patients with overweight or morbid obesity without indication to bariatric surgery. For this purpose, the investigators conduct a retro-prospective cohort study including patients with overweight or moderate obesity undergoing endoscopic sleeve gastroplasty between March 2017 and March 2023
Read the detailed description
The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI >40 kg/m2 or >35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty). The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.
- Conditions
- Obesity
- Being tested
- OBPLUS Clinical Database : data analysis, Biological collection "Liver, bile ducts and pancreas": sample analysis
- Keywords
- Obesity, Endoscopic sleeve gastroplasty, Weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBPLUS Clinical Database : data analysisOther
The data processed relates to patients cared for in the Hepato-gastroenterology and nutrition department of the Antoine Béclère Hospital at the Assistance Publique - Hôpitaux de Paris (AP-HP. All of the clinical and paraclinical data are collected during the visits and entered into the OBPLUS database (database registered in the AP-HP register). These data will be analyzed in order to identify the predictive factors of the effectiveness of the fundo-plication.
Biological collection "Liver, bile ducts and pancreas": sample analysisOther
The samples (plasma, serum, saliva, stool) collected during the samples taken as part of the patient's care were the subject of a biological collection "Liver, bile ducts and pancreas". These samples will be analyzed in order to identify the predictive factors of the effectiveness of the fundo-plication.
| Study group | Role | What they receive |
|---|---|---|
| Moderately obese patients | Moderately obese patients undergoing endoscopic sleeve gastroplasty Receives: Other: OBPLUS Clinical Database : data analysis; Other: Biological collection "Liver, bile ducts and pancreas": sample analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery)
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics mass spectrometry.
Measured: Before endoscopic sleeve gastroplasty
Secondary outcomes (14)
Clinical parameters at baseline and then at 3 and 12 month post-intervention.
Weight expressed in kg, percentage of total weight loss and percentage of excessed weight loss will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention.
Basic serum lipid profile will be analysed by spectrometry as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention.
Glycated hemoglobin expressed in % will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Insulin at baseline and then at 3 and 12 month post-intervention.
Insulin expressed in mUI/l will be analysed as it is systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
C peptide at baseline and then at 3 and 12 month post-intervention.
C peptide expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Ferritin at baseline and then at 3 and 12 month post-intervention.
Ferritin expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention.
ALT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention.
AST levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention.
GGT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention.
ALP levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention
Transient elastometry expressed in kPa will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention.
Controlled attenuation parameter expressed in dB/m will be analysed as they are systematically available in usual clinical practice.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Serum metabolites using widely targeted metabolomics at baseline and then at 3 and 12 month post-intervention.
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics by mass spectrometry.
Measured: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Complications of endoscopic sleeve gastroplasty
Data on the potential complications (occurrence of perforation, bleeding, peritonitis and other infections, thrombo-embolic events and death) of endoscopic sleeve gastroplasty will be collected.
Measured: During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start2 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, INSERM U996
- Responsible party
- Sponsor
- Investigators
- Cosmin VOICAN, MD, PhD, Principal investigator, APHP, Antoine-Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750134
- Sponsor's protocol ID
- APHP230192
- Acronym
- PLICATURE
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sleeve Gastroplasty for Overweight or Moderately Obese Patients: Identification of Predictive Factors for Weight Loss
- ClinicalTrials.gov ID
- NCT05750134
- Acronym / sponsor ID
- PLICATURE / APHP230192
- Conditions
- Obesity
- Keywords
- Obesity, Endoscopic sleeve gastroplasty, Weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, INSERM U996
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 1 Mar 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.
Weight loss is of paramount importance to ameliorate obesity-related complications. Endoscopic sleeve gastroplasty is a new therapeutic option to obtain significant weight reduction in obese patients. Nevertheless, a only a part of patients experience sufficient weight loss to improve comorbidities. A better understanding of mechanisms driving body weight trajectory after endoscopic sleeve gastroplasty may help patient selection and improve efficacy. The main aim of this study is to identify factors associated with weight reduction after endoscopic sleeve gastroplasty in patients with overweight or morbid obesity without indication to bariatric surgery. For this purpose, the investigators conduct a retro-prospective cohort study including patients with overweight or moderate obesity undergoing endoscopic sleeve gastroplasty between March 2017 and March 2023
Detailed description
The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI >40 kg/m2 or >35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty). The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderately obese patients | – | Other: OBPLUS Clinical Database : data analysis, Other: Biological collection "Liver, bile ducts and pancreas": sample analysisModerately obese patients undergoing endoscopic sleeve gastroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate obesity undergoing endoscopic sleeve gastroplasty
Key inclusion criteria (4 listed)
- Age ≥18 years
- Patients giving their consent for the study
- Body mass index between 28 and 35 kg/m2 with co-morbid condition (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, non-alcoholic fatty liver disease or invalidating joint pain)
- No weigh loss following life-style changes
Key exclusion criteria (8 listed)
- Antibiotic treatment during the three previous months
- Patients at risk of gastric cancer requiring regular endoscopic surveillance
- Gastric localization of Crohn disease
- Portal hypertension
- Severe hepatic or renal failure
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 |
|---|---|---|
| OBPLUS Clinical Database : data analysisThe data processed relates to patients cared for in the Hepato-gastroenterology and nutrition department of the Antoine Béclère Hospital at the Assistance Publique - Hôpitaux de Paris (AP-HP. All of the clinical and paraclinical data are collected during the visits and entered into the OBPLUS database (database registered in the AP-HP register). These data will be analyzed in order to identify the predictive factors of the effectiveness of the fundo-plication. | Other | Moderately obese patients |
| Biological collection "Liver, bile ducts and pancreas": sample analysisThe samples (plasma, serum, saliva, stool) collected during the samples taken as part of the patient's care were the subject of a biological collection "Liver, bile ducts and pancreas". These samples will be analyzed in order to identify the predictive factors of the effectiveness of the fundo-plication. | Other | Moderately obese patients |
Primary outcome
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery)
Time frame: Before endoscopic sleeve gastroplasty
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics mass spectrometry.
14 secondary outcomes
Clinical parameters at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Insulin at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
C peptide at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Ferritin at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Serum metabolites using widely targeted metabolomics at baseline and then at 3 and 12 month post-intervention.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Complications of endoscopic sleeve gastroplasty
Time frame: During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
Cosmin VOICAN, MD, PhD principal investigator
APHP, Antoine-Béclère Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 5 May 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery) (time frame: Before endoscopic sleeve gastroplasty). 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 5 May 2026.