RecruitingInterventional

Aniracetam for prevention of hypoglycemia in type 1 diabetes

This study is investigating a supplement called aniracetam to help people with Type 1 diabetes. The main goal is to find better ways to prevent low blood sugar, known as hypoglycaemia, which is a common and sometimes serious side effect of insulin treatment. While current treatments focus on reacting to low blood sugar, this study hopes to find a preventative approach. Researchers believe aniracetam might improve blood sugar control and reduce hypoglycaemic episodes, ultimately enhancing the well-being of those with Type 1 diabetes. It involves a small group of participants and includes carefully monitored visits to see how aniracetam affects the body's response during low blood sugar levels. The study is running from October 2024 to December 2027 in Edinburgh.

At a glance

Status

Recruiting

Sponsor

Leona M. and Harry B. Helmsley Charitable Trust

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Jul 2027

Type 1 Diabetes

What is this study about?

Living with Type 1 diabetes means needing insulin every day to manage your blood sugar. A common challenge with insulin treatment is experiencing hypoglycaemia, which is when your blood sugar drops too low. This can be very unsettling and sometimes dangerous, leading to confusion, seizures, or even a coma. While people usually feel the warning signs of low blood sugar, some individuals can develop 'hypoglycaemia unawareness', meaning their body doesn't signal these drops, putting them at much higher risk.

Currently, there isn't a specific treatment to prevent low blood sugar caused by insulin. Most efforts focus on monitoring blood sugar and taking sugar or a medicine called glucagon when levels drop. However, these methods aren't always perfect, especially for those who don't feel their low blood sugar. This study aims to explore a new approach by looking into a supplement called aniracetam. Researchers hope it might work by affecting how the body reacts to low blood sugar, potentially offering a preventative option alongside existing treatments.

By understanding if aniracetam can help the body cope better during low blood sugar, the study hopes to reduce the number of hypoglycaemic episodes. If successful, this could significantly improve the daily lives and overall health of people with Type 1 diabetes, offering a new way to manage this difficult side effect.

Key takeaways

The study explores a supplement (aniracetam) to prevent low blood sugar in Type 1 diabetes.
It aims to reduce dangerous hypoglycaemic episodes and improve daily life.
Involves three visits to Edinburgh, including two supervised low blood sugar tests.
Participants must be 21-65 years old with Type 1 diabetes for 5+ years.
This is a 'double-blind' study, meaning neither you nor the researchers know who gets the active supplement.
The study is backed by The Helmsley Charitable Trust and run by Professor Shareen Forbes.

Who may be eligible?

This study is looking for volunteers who are between 21 and 65 years old and have been living with Type 1 diabetes for at least five years.

There are certain reasons why you might not be able to join. For example, if you've recently had a very serious low blood sugar event requiring help from others, or a severe complication related to your diabetes. They also cannot include individuals with certain health conditions like severe eye problems (proliferative retinopathy), some heart problems, epilepsy, or certain blood disorders.

Additionally, you can't be pregnant or planning to get pregnant, or taking certain medications that might affect your blood sugar levels. You'll also need to be able to speak and understand English well to ensure your safety during the study procedures.

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 21 and 65 years old?
Have you had Type 1 diabetes for at least 5 years?
Are you able to speak and understand English well?
Are you not currently pregnant or planning to get pregnant?
Have you not had a very serious low blood sugar event requiring outside help in the last 6 months?
Do you not have certain specific health conditions like severe eye problems or serious heart issues?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have three visits to the Edinburgh Royal Clinical Research Facility. The first visit is a screening visit, where they will do blood tests to make sure you are suitable for the study. After that, you will have two special visits called 'hypoglycaemic clamp studies', which will be spread out over one to two months.

Each clamp study visit will last about 6 hours. During this time, your blood sugar will be carefully and slowly lowered to very low levels under close medical supervision. They will take blood samples to see how your body reacts. In one of these visits, they will test your body's response on its own, and in the other, they will test your body's response while you are taking the aniracetam supplement.

Potential risks and benefits

A potential benefit of this study is that if aniracetam proves to be helpful, it could lead to new ways to prevent the challenging and sometimes dangerous effects of low blood sugar in people with Type 1 diabetes, potentially improving their quality of life. The study involves a 'clamp study' procedure, which is a well-established and carefully controlled method used in diabetes research. While the study states there are no specific risks beyond this standard procedure, it's normal to feel a bit anxious about having your blood sugar intentionally lowered. Remember, you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Edinburgh Royal Infirmary Clinical Research Facility
City only
Edinburgh, United Kingdom

Common questions

What is hypoglycaemia?

Hypoglycaemia is when your blood sugar drops too low. It can make you feel unwell and, if severe, can be dangerous.

What is aniracetam?

Aniracetam is a supplement that the study is investigating to see if it can help prevent low blood sugar in Type 1 diabetes.

How long will the study run?

The study is expected to run from October 2024 to December 2027.

Where is the study taking place?

The study is taking place at the Edinburgh Clinical Research Facility in Scotland, UK.

Will I know if I'm getting aniracetam or a dummy treatment?

No, this is a 'double-blind' study, meaning neither you nor the research team will know who is receiving aniracetam and who is receiving the dummy treatment until after the study is complete. This helps ensure fair and accurate results.

How to find out more

Shareen Forbes

Shareen.Forbes@ed.ac.uk +44 1312426736 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.