Clinical trial NCT05750134: Endoscopic Sleeve Gastroplasty for Moderate Obesity
Official title: Endoscopic Sleeve Gastroplasty for Overweight or Moderately Obese Patients: Identification of Predictive Factors for Weight Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Obesity
Endoscopic sleeve gastroplasty
Weight loss
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: INSERM U996
First posted: 2023-03-01
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate obesity undergoing endoscopic sleeve gastroplasty

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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)
timeFrame: Before endoscopic sleeve gastroplasty
Secondary outcomes:
measure: Clinical parameters at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Insulin at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: C peptide at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Ferritin at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Serum metabolites using widely targeted metabolomics at baseline and then at 3 and 12 month post-intervention.
timeFrame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
measure: Complications of endoscopic sleeve gastroplasty
timeFrame: During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12
Other outcomes:
Locations:
Study officials:
affiliation: APHP, Antoine-Béclère Hospital
name: Cosmin VOICAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: