PHARMATOPTopiramate for Weight Loss in Youth with Severe Obesity
The study aims to evaluate if topiramate can help reduce body mass index in young individuals with severe obesity over three months.
Topiramate Tablets
Body Weight+6
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: April 4, 2022
Actual date on which the first participant was enrolled.This study focuses on understanding how the drug Topiramate helps with weight loss in young people who have severe obesity. Topiramate is believed to reduce appetite, cravings, and certain eating habits, which may help with losing weight. Researchers aim to find out why Topiramate works better for some individuals than others, by looking at specific factors like age, body mass index (BMI), and sex. This is important because it could lead to more personalized treatments for young people struggling with obesity, potentially improving their health outcomes. Participants in the study will take Topiramate and have their drug levels monitored over a period of 3.5 months to see how it affects their weight and eating behaviors. The study will measure changes in BMI, which is a way to see how much weight a person has lost relative to their height. By using advanced models, researchers will analyze how the drug exposure correlates with changes in weight and eating patterns. This will help determine if certain characteristics make the drug more effective for some young individuals, paving the way for tailored obesity treatments. The study involves regular check-ins and measurements, ensuring safe monitoring of participants' health throughout the process.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.62 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location