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IRCT20230408057842N2 IRCT 2023-10-22 Shahid Beheshti University of Medical Sciences The effect of botulinum in obese patients Exploring Intragastric Botulinum Toxin Injections: A Prospective study on the rate of Weight Loss in Overweight and Obese Patients 2023-11-06 anticipated 60 Complete https://irct.ir/trial/73076 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, the person evaluating the outcomes in both intervention and control groups does not know which group each patient is assigned to. Also, the names of the patients along with their other information are provided to the analyst in coded form to avoid any bias. 3 Overweight and obesity. Intervention 1: Intervention group: The intervention group receives intragastric botulinum toxin injections under endoscopic guidance. Patients in the intervention arm will receive 5cc containing 500units of Botulinum Toxin A (Masport; MasoonDarou Pharmaceutical Company; Iran) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 10 separate injections of 1.5ml each will be performed in a concentric ring 5cm apart. A total of 50 units of botulinum toxin are injected at 10 sites in the stomach, targeting antrum 5cm above the pylorus (3 points), body (5 points), and fundus (2 points). Also, they receive a limited diet with specific calories. Intervention 2: Control group: Participants receive standardized nutritional counseling by a registered dietitian. They are given specific calorie-restricted diets that aim to lose 0.5-1 kg of weight per week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is keeping patient confidentiality
public Alireza Zahedi
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 a.zahedi2013@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammad Javad Ehsani Ardakani
Arabi street, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 2525 mjehsani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Body mass index (BMI) between 25-39.9 kg/m^2 Willingness to participate in the intervention Absence of any other comorbidity Absence of any contraindications for botulinum toxin administration 18 years no limit Both Participants with a history of previous bariatric surgery BMI≥40 kg/m^2 Known allergy to any ingredients in Masport or allergic reaction Pregnancy or lactation Known pre-existing neuromuscular disorders or peripheral motor neuropathic disease (e.g. amyotrophic lateral sclerosis, motor neuropathy) Patients with known liver cirrhosis or known esophageal/gastric varices Known eating disorders Known major cardiovascular or pulmonary conditions Diabetes Pathologic changes of the esophagus/stomach/duodenum demonstrated on endoscopy (esophagitis, peptic ulcers, cancer) Known alcohol or drug abuse E66 Overweight and obesity Treatment - Surgery Lifestyle Intervention group: The intervention group receives intragastric botulinum toxin injections under endoscopic guidance. Patients in the intervention arm will receive 5cc containing 500units of Botulinum Toxin A (Masport; MasoonDarou Pharmaceutical Company; Iran) diluted to 10mls of saline. Endoscopy will be performed using a single-lumen gastroscope. Injection of the solution will be done using a 23Gauge Interject needle catheter. 10 separate injections of 1.5ml each will be performed in a concentric ring 5cm apart. A total of 50 units of botulinum toxin are injected at 10 sites in the stomach, targeting antrum 5cm above the pylorus (3 points), body (5 points), and fundus (2 points). Also, they receive a limited diet with specific calories. Control group: Participants receive standardized nutritional counseling by a registered dietitian. They are given specific calorie-restricted diets that aim to lose 0.5-1 kg of weight per week. Weight. Timepoint: before the intervention and three months later. Method of measurement: scales. Body mass index. Timepoint: before the intervention and three months later. Method of measurement: Height to weight ratio formula. Waist circumference. Timepoint: before the intervention and three months later. Method of measurement: meter. Hip circumference. Timepoint: before the intervention and three months later. Method of measurement: meter. Waist-to-hip ratio. Timepoint: before the intervention and three months later. Method of measurement: waist-to-hip ratio formula. Arm circumference. Timepoint: before the intervention and three months later. Method of measurement: meter. Lipid profile. Timepoint: before the intervention and three months later. Method of measurement: laboratory kits. Blood glucose. Timepoint: before the intervention and three months later. Method of measurement: laboratory kits. HbA1c. Timepoint: before the intervention and three months later. Method of measurement: laboratory kits. Side effects. Timepoint: before the intervention and three months later. Method of measurement: Patient examination and history. Patients' satisfaction with each method. Timepoint: before the intervention and three months later. Method of measurement: Questionnaire of satisfaction with weight loss program. Shahid Beheshti University of Medical Sciences Approved 2023-09-04 research ethic committee of research institute for gastroenterology and liver disease Arabi street, Velenjak Tehran Tehran Iran (Islamic Republic of)