Endoscopic Sleeve Gastroplasty for Moderate Obesity

Obesity Clinical Trial

— PLICATURE  

Official title:

Endoscopic Sleeve Gastroplasty for Overweight or Moderately Obese Patients: Identification of Predictive Factors for Weight Loss

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05750134
• Other study ID #: APHP230192
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: October 2023

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Cosmin VOICAN, MD, PhD
• Phone: +33 1 45 37 47 75
• Email: cosmin.voican[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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: 105
• Est. completion date: October 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• OBPLUS Clinical Database : data analysis
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 analysis
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	INSERM U996, Metabolomics platform/UMR 1138 INSERM

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