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

NCT06153056 | Recruiting

• 2 other identifiers: APHP2308822023-A01226-39
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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

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

Interventions

Bloed-, ontlasting- en speekselmonsters DIAGNOSTIC_TEST

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.

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

Major grade I obese patients (BMI between 30 and 35 kg/m²) not eligible for sleeve gastrectomy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Antoine Béclère

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples (blood, plasmatheque, serotheque, stool) taken as part of the research will be will be collected in a biological collection. 12 mL blood on dry tube, 12 mL on EDTA tube, for a total of 24 mL of blood, will be collected at each research visit. 5 aliquots of serum and 5 aliquots of plasma of 0.5 mL will be kept. An aliquot of 1 mL of whole blood will be stored. 10 aliquots of approximately 2 mL of stool. 1 saliva swab of saliva will be collected and stored. These collections will be kept at the biochemistry and bacteriology laboratory of the Antoine Béclère hospital, for a period of 30 years. At the end of the research, the samples may be used for further analyses not provided for in the protocol, which may prove to be of interest. that may be of interest in the context of obesity pathology, depending on the obesity, in line with the development of scientific knowledge, subject to the patient's informed, as indicated in the information/consent form.

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

Central Study Contacts

Cosmin VOICAN, MD, PhD

CONTACT

1 45 37 47 75; cosmin.voican@aphp.fr

Gabriel PERLEMUTER, MD, PhD

CONTACT

1 45 37 47 75; gabriel.perlemuter@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: September 9, 2025
• Primary Completion (Estimated): February 2, 2031
• Study Completion (Estimated): February 2, 2031
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)