RecruitingNAINTERVENTIONAL

The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes

The GAPSID Study explores how medicines known as GLP-1 analogues compare to metformin in preventing high blood sugar when someone takes a common steroid called dexamethasone. Steroids can sometimes lead to a type of diabetes called steroid-induced diabetes. Researchers want to understand the exact ways these medicines work to keep blood sugar levels stable, hoping to find better ways to treat or even prevent this condition. Participants will take either an oral GLP-1 medicine, metformin, or a dummy pill (placebo) while also taking a steroid for seven days. The study will measure how their bodies handle sugar before and after taking these medications.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

15 May 2024

Estimated completion

01 Jun 2027

Steroid-Induced Diabetes Steroid Induced Hyperglycemia

What is this study about?

Steroids are powerful medicines often used to reduce swelling and pain in many different health conditions. While they are very helpful, one common side effect can be that they make blood sugar levels go up. For some people, especially those already at risk, this can even lead to a type of diabetes called 'steroid-induced diabetes.' This study, called The GAPSID Study, aims to understand how we might prevent this from happening.

We're looking at two types of medicines that are already used for diabetes: GLP-1 analogues and metformin. GLP-1 analogues are newer medicines that help your body make more insulin when blood sugar rises, and also help you feel full faster. Metformin is a well-established medicine that helps your body use insulin more effectively. The study wants to find out which of these, if either, is better at keeping blood sugar levels stable when someone is taking steroids, and importantly, how they actually work inside the body.

By comparing these medicines to each other, and to a 'dummy' pill (placebo), researchers hope to learn more about the best ways to protect people from developing high blood sugar and steroid-induced diabetes when they need to take steroids. This could lead to better guidelines for doctors and improved care for patients in the future.

Key takeaways

This study aims to prevent high blood sugar caused by steroids.
It compares two diabetes medicines (GLP-1 analogues and metformin) to a dummy pill.
Participants will have pre-diabetes or mild, lifestyle-managed diabetes.
The study involves taking a steroid and study medicine for 7 days, plus monitoring.
The goal is to find better ways to protect people from steroid-induced diabetes.

Who may be eligible?

This study is looking for adults aged 18 or older. We are particularly interested in people who have been told they have 'pre-diabetes' or a mild form of diabetes that is currently managed through diet and exercise, not with medication.

There are also some important reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or have recently taken certain diabetes medicines or steroids. Also, if you have specific conditions like a history of serious heart, kidney, or liver problems, or certain stomach issues, you might not be suitable.

It's important to discuss your full medical history with the study team, including any medicines you take, to determine if this study is right and safe for you.

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?
Do you have pre-diabetes or diabetes controlled by diet/exercise (not medication)?
Are you currently not pregnant or breastfeeding?
Have you avoided certain diabetes or steroid medications in the past 3 months?
Do you have a BMI of 22.5 or higher?
Do you have any serious heart, kidney, or liver conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about three weeks in total for you. It starts with about ten days where you'll wear a small device to continuously monitor your blood sugar levels. After that, you'll take a low dose of a steroid called dexamethasone for seven days. During these seven days, you'll also be taking either an oral GLP-1 medicine, metformin, or a dummy pill (placebo).

Throughout the study, you'll come to the clinic for various tests. These include blood tests, especially to see how your body handles sugar after a special meal or with specific sugar solutions given through a vein. Some participants will also have small tissue samples taken from fat and muscle to get a closer look at how the medicines work. After you've finished the seven days of medication, you'll have one final check-up visit about 3 to 5 days later.

Potential risks and benefits

Taking part in this study could help us learn more about preventing steroid-induced diabetes, which could benefit many people in the future. As with any medicine, there's a chance you might experience side effects from the study drugs (GLP-1 analogue, metformin, or dexamethasone), such as stomach upset or changes in blood sugar. The tissue biopsies also carry a small risk of bruising or discomfort. All study procedures will be explained in detail, and your safety will be closely monitored. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'steroid-induced diabetes'?

It's when your blood sugar levels become too high because you are taking steroid medicines, even if you didn't have diabetes before.

What are GLP-1 analogues and Metformin?

They are medicines commonly used to help manage type 2 diabetes by helping your body control blood sugar levels.

Will I know if I'm getting a real medicine or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the study team will know until after the study is over. This helps make the results fair.

What is 'pre-diabetes'?

Pre-diabetes means your blood sugar levels are higher than normal but not high enough yet to be diagnosed with type 2 diabetes.

How long will I be in the study?

Your direct involvement in the study will be for about three weeks.

How to find out more

Katharine Lazarus, MBChB, BSc

k.lazarus@imperial.ac.uk 07555717544 Official trial record

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