A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preservation of beta-cell function (VER-A-T1D)
This research study is for adults who have recently been diagnosed with type 1 diabetes. It's looking into whether a medicine called Verapamil can help people with this condition continue to produce some of their own insulin. In type 1 diabetes, the body's immune system mistakenly attacks and destroys the cells in the pancreas (called beta cells) that make insulin, which is essential for controlling blood sugar. The study aims to see if Verapamil can protect these beta cells and help them keep working for longer. Participants will either receive Verapamil or a dummy pill (placebo) for 12 months. Researchers will measure how much insulin their body produces over time to understand the drug's effect. This is an early-stage study, hoping to find new ways to manage type 1 diabetes.
At a glance
What is this study about?
When someone is diagnosed with type 1 diabetes, their body's immune system has unfortunately started to destroy the special cells in the pancreas called 'beta cells'. These beta cells are super important because they're the ones that make insulin, which helps your body use sugar for energy. Without enough insulin, blood sugar levels become too high. Even after diagnosis, some beta cells might still be working.
This study is looking at whether a specific medicine, Verapamil, can help protect these remaining beta cells. If Verapamil could encourage these cells to keep working for longer, it might mean people with type 1 diabetes could continue to produce some of their own insulin, which could make managing the condition easier and potentially lead to better long-term health. Think of it like trying to shield these important cells from further damage. It's an exciting area of research to find new ways to help people living with type 1 diabetes.
The study involves giving some participants Verapamil and others a dummy pill (placebo). This is done so researchers can fairly compare if any changes are truly due to the Verapamil or something else. They'll carefully monitor how much insulin people's bodies are making over a year, alongside other health markers, to understand if Verapamil makes a meaningful difference.
Key takeaways
- This study is for adults recently diagnosed with type 1 diabetes.
- It's exploring if Verapamil can help protect insulin-making cells (beta cells).
- Participants will take either Verapamil or a dummy pill for 12 months.
- The main goal is to see if insulin production is preserved.
- Your routine diabetes care will continue with your existing healthcare team.
- It's a research study, so direct benefits can't be guaranteed, but it helps advance knowledge.
Who may be eligible?
This study is looking for adults who are 18 years old or older. There is no upper age limit for taking part.
To be eligible, you must have been very recently diagnosed with type 1 diabetes. The exact timeframe for this 'recent diagnosis' would be discussed by the study team, as it's crucial for the research goals.
Both men and women can take part in this study, provided they meet all the other requirements. The study team will review your medical history and conduct tests to make sure it's safe and appropriate for you to participate.
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 18 years old or older?
- Have you been diagnosed with type 1 diabetes very recently?
- Are you able and willing to attend regular study visits for a year?
- Are you generally in good health, apart from your type 1 diabetes?
- Are you comfortable with blood tests and an oral meal tolerance test?
What does participation involve?
If you decide to take part in this study, you would primarily receive either the study drug, Verapamil, or a placebo (a dummy pill that looks the same but contains no active medicine). You would take this medication for 12 months. Throughout this time, you would have regular visits to the study centre for check-ups and tests. These tests would include blood samples to measure things like your insulin production and blood sugar levels. You would also undergo a special test called a 'mixed meal tolerance test' (MMTT) at different points. This involves drinking a special meal replacement drink and then having blood samples taken over a couple of hours to see how your body responds and makes insulin. Your diabetes team will continue to manage your day-to-day diabetes care and insulin needs. There would be follow-up checks for up to 24 months in total.
Potential risks and benefits
Locations (5)
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- —UnverifiedAustria
Common questions
What is Type 1 Diabetes?
Type 1 diabetes is a condition where your body's immune system mistakenly attacks and destroys the cells in your pancreas that produce insulin, a hormone essential for controlling blood sugar.
What are 'beta cells'?
Beta cells are special cells in your pancreas that are responsible for making and releasing insulin into your body.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It's used in studies to fairly compare the effects of the actual drug.
What is a 'mixed meal tolerance test' (MMTT)?
It's a test where you drink a special liquid meal, and then blood samples are taken over the next two hours to see how your body responds and if your pancreas releases insulin.
Will my own doctor still look after my diabetes?
Yes, your regular diabetes care team will continue to manage your daily diabetes treatment and provide your usual medical care throughout the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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