Obesity. Overweight and obesity
Conditions
Interventions
Intervention 1: Intervention group: Gastric fundus mucosal ablation using Hybrid Argon Plasma Coagulation after submucosal injection of saline mixed with methylene blue to create a protective cushion,
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Body mass index (BMI) greater than 27 kg/m² Willingness and ability to provide informed consent Willingness to adhere to follow-up schedule and dietary recommendations No history of previous bariatric surgery or major upper gastrointestinal surgery Eligibility for upper gastrointestinal endoscopy and sedation No contraindication to botulinum toxin injection
Exclusion criteria
Exclusion criteria: Known allergy to botulinum toxin or its components Pregnancy or lactation Neuromuscular disorders such as myasthenia gravis or multiple sclerosis Liver cirrhosis or esophageal or gastric varices Pathological findings on baseline endoscopy such as ulcers or malignancy Eating disorders such as bulimia or anorexia Severe cardiovascular or pulmonary disease History of alcohol or substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index. Timepoint: at baseline (before intervention) and 3 months after intervention. Method of measurement: Body mass index calculated based on weight measured by a standard scale and height measured by a stadiometer and calculated as weight divided by height squared in kilograms per square meter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Measured with a tape measure in the mid-region between the last rib and the iliac crest.;Hip circumference. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Measured with a tape measure at the most prominent part of the buttocks.;Arm circumference. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Measurement with a tape measure at the mid-arm.;Blood lipid profile. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Measured by fasting blood test in the laboratory.;Blood sugar. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Measured by fasting blood test in the laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeed Lotfi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed