Obesity is classified as a body mass index (BMI) above 30 kg/m2 by the World Health Organization MedDRA version: 21.1 Level: PT Classification code 10070972 Term: Gastroplasty System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: esomeprazolo
Product Code: [esomeprazolo]
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: esomeprazolo
CAS Number: 161796-78-7
Current Sponsor code: esomeprazolo
Concentrat
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactDIREZIONE SCIENTIFICA
FONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS
Outcome results
None listed