Hôpital Antoine Béclère
Paris, France
Location status: Recruiting
NCT Number: NCT06153056
Endoscopic sleeve gastroplasty and bypass are currently available for weight loss in obese patients who have failed nutritional management. Despite very low risks, these techniques remain invasive. What's more, the French National Authority for Health recommends this procedure for patients with a BMI above 35 kg/m² with associated co-morbidities, or above 40 kg/m². This excludes grade I obese patients (30 < BMI < 35) who have no effective means of losing weight. The hospital's hepato-gastroenterology and nutrition department has therefore implemented endoscopic sleeve gastroplasty to address this problem. As with other surgical techniques, there is heterogeneity heterogeneity in weight loss. The investigators therefore aim to identify factors predictive of the efficacy of this procedure in order to improve patient management of patients.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In addition, the blood collected (24 mL) will be used for the following analyses:
GLP-1, PYY, branched-chain amino acids, Adipokines, leptin, adiponectin Blood bile acid levels: total and detailed analyzed by HPLC MS/MS Serum microbiome profile Genome-wide association study.
The stool sample will be used to establish the :
Intestinal bile acid profile Intestinal microbiota profile Saliva sampling for oral microbiota profiling.
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.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
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.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Basic serum lipid profile will be analysed by spectrometry as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Glycated hemoglobin expressed in % will be analysed as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Insulin expressed in mUI/l will be analysed as it is systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
C peptide expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Ferritin expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
ALT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
AST levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
GGT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
ALP levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Transient elastometry expressed in kPa will be analysed as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Controlled attenuation parameter expressed in dB/m will be analysed as they are systematically available in usual clinical practice.
Time frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics by mass spectrometry
Time frame: During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12
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.
Contact information is provided by the study sponsor or research team.
Cosmin VOICAN, MD, PhD
CONTACT
1 45 37 47 75 ext. +33
Gabriel PERLEMUTER, MD, PhD
CONTACT
1 45 37 47 75 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty & Study the Evolution of Clinical, Biological and Intestinal Intestinal Microbiota After Surgery
Acronym: PREDISLEGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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