Metformin Intervention in children and adolescents with obesity. A parallel, three arms, randomized, 6 months, multi-center study with metformin extended release (XR) plus lifestyle or metformin immediate release (IR) plus lifestyle or lifestyle alone.
This study is investigating whether a common medicine called metformin can help children and teenagers who are overweight. Researchers are comparing two versions of metformin – one that works quickly and one that works slowly – both given alongside advice on healthy eating and exercise. They are also comparing these approaches to just having lifestyle advice on its own. The main goal is to see how these treatments affect a child's weight and size over six months. This is an early-stage study, meaning it's helping scientists learn more about how metformin might work for this age group and whether it's a promising area for future research. It includes participants of all ages and genders within the child and adolescent categories.
At a glance
What is this study about?
This research study is about helping children and teenagers who are living with obesity. Doctors and scientists are looking into whether a medicine called metformin could be a helpful tool, alongside good lifestyle habits like healthy eating and regular exercise. Metformin is a medicine that's often used to help people with type 2 diabetes manage their blood sugar, and it can also sometimes help with weight.
The study will look at two different ways metformin is given: one is a tablet that works quite quickly in the body, and the other is a special tablet that releases the medicine slowly over time. Both of these ways of taking metformin will be combined with advice on how to live a healthy lifestyle. There will also be a group of children and teenagers who only receive the healthy lifestyle advice, so researchers can compare the different approaches.
The main aim over the six months of the study is to see how these different groups change in terms of their body mass index (BMI), which is a way of measuring a healthy weight for a person's height. They will also be looking at many other things to understand the overall health effects, such as general well-being, blood sugar levels, and how the medicine is handled by the body.
Key takeaways
- This study evaluates metformin medicine with lifestyle changes for children and teens with obesity.
- It compares two forms of metformin (fast-acting and slow-release) against lifestyle changes alone.
- The primary goal is to assess changes in weight over six months.
- Participation involves regular clinic visits, health checks, and possibly taking medication.
- Families can withdraw from the study at any time without affecting regular care.
Who may be eligible?
This study is for children and teenagers who are living with obesity. It includes both boys and girls across the entire range of childhood and adolescence.
There aren't specific age limits mentioned, but generally, 'children and adolescents' would refer to individuals typically under 18 years old. The researchers will be able to tell you if your child fits the specific criteria for joining. It's important to discuss your child's full medical history with the study team to make sure it's safe and appropriate for them to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child under 18 years old?
- Has my child been diagnosed with obesity by a healthcare professional?
- Is my child generally healthy, apart from their weight?
- Am I, as a parent or guardian, able to commit to the study's appointments and requirements?
What does participation involve?
If your child joins this study, they will be randomly placed into one of three groups: one group will take the fast-acting metformin tablets plus get lifestyle advice; another group will take the slow-release metformin tablets plus get lifestyle advice; and the third group will only receive lifestyle advice. This is a "randomized" study, meaning neither you nor the researchers choose which group your child is in, to make the comparison fair.
Over six months, your child would have regular visits to the study clinic. At these visits, doctors and nurses will monitor their health closely. This will involve regular check-ups, measuring their height and weight, taking blood and urine samples to check things like blood sugar and how the medicine is working in their body, and perhaps asking them to fill out questionnaires about their diet and activity. They will also check vital signs like blood pressure and heart rate. The study will look at different aspects of their health, including how their body handles sugar and fats, and their overall growth and development. After the six months, there will likely be follow-up to see how things are going.
Potential risks and benefits
Locations (1)
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Common questions
What is obesity in children and teens?
Childhood and adolescent obesity means a child carries more weight than is considered healthy for their age and height. Doctors measure this using something called BMI-SDS (Body Mass Index - Standard Deviation Score).
What is metformin?
Metformin is a common medicine, usually used to help people with type 2 diabetes manage their blood sugar. Sometimes, it's also looked at for other uses, like helping with weight management.
What does 'lifestyle changes' mean in this study?
This refers to advice and support on healthier eating habits and getting more physical activity to help manage weight and improve overall health.
Why are there different types of metformin?
Researchers are comparing a 'fast-acting' metformin with a 'slow-release' metformin to see if one works better or has fewer side effects for children and teenagers.
How long will my child be in the study?
The main part of the study will last for six months, involving regular appointments during that time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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