Endoscopic Sleeve Gastroplasty for Moderate Obesity

NCT05750134 | Completed

• 1 other identifier: APHP230192
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

Obesity; Endoscopic sleeve gastroplasty; Weight loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Clinical parameters at baseline and then at 3 and 12 month post-intervention.

  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.

  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.

  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.

  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.

  Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12

Study Arms (1)

Moderately obese patients

Moderately obese patients undergoing endoscopic sleeve gastroplasty

Other: OBPLUS Clinical Database : data analysis; Other: Biological collection "Liver, bile ducts and pancreas": sample analysis

Interventions

Biological collection "Liver, bile ducts and pancreas": sample analysis OTHER

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.

Moderately obese patients

OBPLUS Clinical Database : data analysis OTHER

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.

Moderately obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate obesity undergoing endoscopic sleeve gastroplasty

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• INSERM U996: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

AP-HP, Antoine Béclère Hospital, Department of Hepatology, Gastroenterology, and Nutrition

Clamart, 92140, France

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Cosmin VOICAN, MD, PhD

  APHP, Antoine-Béclère Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: March 1, 2023
• Study Start: January 2, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)