Overweight and obesity. Overweight and obesity
Conditions
Interventions
Intervention 1: Intervention group: The intervention group receives intragastric botulinum toxin injections under endoscopic guidance. Patients in the intervention arm will receive 5cc containing 500u
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
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Zahedi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed