Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty

Obesity Clinical Trial

— PREDISLEGE  

Official title:

Identification of Factors Predictive of the Efficacy of Endoscopic Endoscopic Sleeve Gastroplasty & Study the Evolution of Clinical, Biological and Intestinal Intestinal Microbiota After Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06153056
• Other study ID #: APHP230882
• Secondary ID: 2023-A01226-39
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: May 2029

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Cosmin VOICAN, MD, PhD
• Phone: 1 45 37 47 75
• Email: cosmin.voican[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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. We therefore aim to identify factors predictive of the efficacy of this procedure in order to improve patient management of patients.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 205
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient of legal age (Age = 18 years)

• Patient capable of understanding the study and signing a consent.

• BMI between 30 and 35 kg/m² with the presence of at least one one obesity-related complication (diabetes, dyslipidemia, sleep apnea syndrome, non-alcoholic steatohepatitis, joint pain joint pain).

• Patients with a BMI greater than 35 kg/m² who have been bariatric surgery has been refused.

• Patient who has failed to lose weight and improve with conventional techniques.

• Patient affiliated to a social security scheme

Exclusion Criteria:

• Patient having taken antibiotics 3 months prior to inclusion.

• Patient under legal protection.

• Patient at risk of gastric cancer requiring regular endoscopic surveillance: extensive intestinal atrophy and/or metaplasia on biopsy.

• Patient with a history of gastrointestinal inflammatory disease of gastric localization, hepatic or renal insufficiency, portal hypertension.

• Patient with evidence of peptic ulcer disease and/or progressive peptic ulcer disease.

• Patient with pathology affecting general health health and/or life expectancy.

• Patient with a history of bariatric surgery.

• Patient on AME

Related Conditions & MeSH terms

• Obesity

Intervention

Diagnostic Test:
• Bloed-, ontlasting- en speekselmonsters
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before endoscopic sleeve gastroplasty
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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	Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Secondary	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.	During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12