Overweight and obesity. Overweight and obesity
Conditions
Interventions
Intervention 1: Intervention Group :Patients in the intervention group will undergo an endoscopic procedure to inject Botulinum Toxin A (BTX-A) into the stomach after fasting for 6 to 12 hours. A seda
Sponsors
Bandare-abbas University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 65 years Body Mass Index (BMI) greater than 27 kg/m² Provision of written informed consent after receiving a detailed explanation of the study process General good health with no significant medical conditions that would prevent participation in the study No history of gastric surgery or active gastrointestinal diseases No continuous use of medications that affect gastrointestinal motility
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding. Presence of neuromuscular disorders such as Myasthenia Gravis or Lambert-Eaton Syndrome. Hypersensitivity to Botulinum Toxin Type A (BTX-A) or its components. Active cardiovascular diseases. Active gastrointestinal diseases such as peptic ulcers or cancer History of severe gastric surgery or injury. Uncontrolled diabetes mellitus. Obesity caused by endocrine disorders such as Cushing's syndrome. Continuous use of medications like opioids or anticholinergics that disrupt gastrointestinal motility. Lack of willingness or ability to adhere to study protocols or processes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Loss (kilograms). Timepoint: Time points for measurement will include the following intervals: Day of intervention (before botulinum toxin injection), 2 weeks, 4 weeks, 8 weeks, 16 weeks, and 24 weeks post-intervention. Method of measurement: The weight of patients will be measured using a calibrated digital scale. The device will be placed in a standard clinical environment, and the weight will be recorded in kilograms. Patients will be asked to stand on the scale without shoes and wearing light clothing. This method will be consistently applied across all measurement points to ensure accuracy and uniformity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index. Timepoint: Time points for measurement will include the following intervals: Day of intervention (before botulinum toxin injection), 2 weeks, 4 weeks, 8 weeks, 16 weeks, and 24 weeks post-intervention. Method of measurement: Body Mass Index (BMI) will be calculated using the following formula:Patient's weight (in kilograms) divided by the square of their height (in meters).Weight will be measured using a calibrated digital scale, and height will be measured using a precise stadiometer in a standard clinical environment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSahar Sarani
Bandare-abbas University of Medical Sciences
Outcome results
None listed