Effect of proton pump inhibitors on the structural integrity of endoscopic sleeve gastroplasty: a single-centre open-label, randomized, controlled pilot clinical trial

Phase 1

• Conditions: Obesity is classified as a body mass index (BMI) above 30 kg/m2 by the World Health Organization; MedDRA version: 21.1Level: PTClassification code 10070972Term: GastroplastySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-000266-15-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-22
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

- Age 20 to 65 years
- BMI between 30 to 45 kg/m2
- Willingness to participate in the study and ability to comply and understand the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Active gastric gastro-duodenal during the last 6 months - Helicobacter pylori infection.- Organic or motility disorder of the stomach and / or esophagus
- Anticoagulant treatment
- Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- Ongoing or active malignancy during the last 5 years.
- Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association’s classification.
- Drug or alcohol abuse
- Bulimic or binge eating pattern
- Continuous glucocorticoid or anti-inflammatory treatment
- Uncontrolled thyroid disease.
- Pregnancy, breastfeeding
- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
- Hiatal hernia = 5 cm
- Currently participating in other study
- Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of this study is to evaluate the effect of PPI’s on the structural integrity of the ESG at 6 and 12 months, evaluated with upper endoscopy. At upper endoscopy the structural integrity of the ESG will be defined as: opened (all stiches loose), partially intact (at least one stich loose) or intact (all stiches tight).;Secondary Objective: Secondary aims are the effects of ESG on weight loss, quality of life, metabolic risk factors and anthropometry and on satiety.;Primary end point(s): The primary end-point of the study is the assess the effect of PPIs on the proportion of patients with Intact ESG” at 6 and 12 months of follow-up.;Timepoint(s) of evaluation of this end point: 6 and 12 months