Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
Living with a learning disability can mean a higher chance of being overweight, partly due to important medicines called antipsychotics. This can lead to serious health issues earlier in life. This study is testing if a common medicine, metformin, can help manage weight gain in adults with learning disabilities who are taking antipsychotics. Currently, there's not much research on this specific group, even though they often face these health challenges. If successful, this study could offer a new, widely available way to tackle weight gain and improve the health and well-being of people with learning disabilities.
At a glance
What is this study about?
People with learning disabilities often face higher risks of being overweight or obese. A big reason for this is the use of certain medications called antipsychotics, which are very important for managing some health conditions. While these medicines are necessary for many, they can cause weight gain, which then increases the risk of other serious health problems like heart disease, earlier in life.
Currently, there isn't much specific research on how to best help people with learning disabilities manage weight gain, especially when it's caused by medications. The treatments that work for others might not always be right for this group because their bodies can be different. This study aims to fill that gap. It's the first major study of its kind to test if a medicine called metformin can help.
Metformin is already a widely used medicine, and this trial will see if it's effective for adults with learning disabilities who have gained weight after starting antipsychotic medicine. If it works, it could provide a simple and accessible way to improve the health and quality of life for a group of people who are often overlooked in medical research.
Key takeaways
- Targets weight gain in adults with learning disabilities on antipsychotics.
- First study to test metformin for this specific group.
- Could offer a new way to improve health and reduce obesity risks.
- Participants will receive either metformin or a dummy pill (placebo).
- Focuses on a group often missed in medical research.
- Aims to create new treatment guidelines if successful.
Who may be eligible?
This study is looking for volunteers between the ages of 16 and 65 who have a learning disability. You should be attending regular outpatient appointments and have been taking antipsychotic medication for at least three months, with your dose staying steady during that time.
To join, you need to be overweight or obese. This means your Body Mass Index (BMI) should be 30 or higher. If your BMI is 27 or higher, you might still qualify if you also have a weight-related health issue like high blood pressure or sleep apnoea. Even if your BMI is 25 or higher, you could be eligible if you've gained over 5% of your body weight since starting your antipsychotic medication.
However, there are some reasons you might not be able to join. For example, if you are pregnant or breastfeeding, have serious heart, kidney, or liver problems, or have previously tried metformin and it didn't work for you. Also, people with type 1 or type 2 diabetes or certain other specific health conditions won't be able to take part. If you're a woman of child-bearing age, you'll need to be using reliable contraception throughout the study.
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.
- Are you between 16 and 65 years old?
- Do you have a learning disability and attend outpatient appointments?
- Have you been on antipsychotic medication for at least 3 months?
- Are you overweight or obese (BMI of 25 or higher, depending on weight gain or other health issues)?
- Are you not currently pregnant or breastfeeding?
- Do you not have serious heart, kidney, or liver conditions that are not well managed?
What does participation involve?
If you join this study, you'll be given either the study drug (metformin) or a dummy pill (placebo) – you won't know which one you're taking. You'll likely have several outpatient visits where the study team will monitor your health, take measurements like your weight, and possibly do blood tests. You'll need to take the study medicine as instructed. The study will also involve some advice on lifestyle, such as diet and exercise. We don't have the exact total duration here, but clinical trials usually last for several months to a year or more to see the full effects.
Potential risks and benefits
Locations (1)
- Centre for Addiction and Mental HealthVerified postcodeToronto, Canada· Recruiting
Common questions
What is metformin?
Metformin is a common medicine often used for type 2 diabetes, but it can also help with weight in some people.
What's a placebo?
A placebo looks just like the real medicine but contains no active drug. It helps researchers see if the real medicine is actually working.
Will I know if I'm getting metformin or the placebo?
No, you won't know. This is called 'blinding' and helps make sure the study results are fair and accurate.
What's an antipsychotic medicine?
Antipsychotic medicines are used to help manage certain mental health conditions, like psychosis. They are important for many people.
What does 'learning disability' mean for this study?
It refers to people with intellectual and developmental disabilities, meaning they may need extra support with daily living and learning.
How to find out more
Mahavir Agarwal, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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