The effect of botulinum in obese patients
- Conditions
- Overweight and obesity.Overweight and obesity
- Registration Number
- IRCT20230408057842N2
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.