SGLT-2i, Heart, Improvement of Cardiovascular Autonomic Neuropathy
Diabetes can sometimes affect the nerves that automatically control your heart rate and blood pressure, a condition known as cardiac autonomic neuropathy. This study is testing whether a common class of type 2 diabetes medications, known as SGLT-2 inhibitors (such as empagliflozin or dapagliflozin), can help protect or improve this nerve function. Over six months, researchers will monitor adults with type 2 diabetes who are taking diabetes medications. They will track changes in heart rate patterns, nerve reflexes, and day-to-day blood sugar swings using wearable sensors and simple heart tests. The team will also see how well the pancreas produces insulin after meals. The overall goal is to find out if these medicines can provide extra protection for the heart and nervous system beyond just lowering blood sugar.
At a glance
What is this study about?
Type 2 diabetes is a lifelong condition that causes the level of sugar in the blood to become too high. Over time, high blood sugar can damage the delicate nerves throughout the body. One important group of nerves controls automatic body functions, such as your heartbeat and blood pressure. When diabetes affects these specific nerves, doctors call it cardiovascular autonomic neuropathy. This can make it harder for your heart to respond smoothly to everyday activities, like standing up or exercising.
In recent years, doctors have started using newer diabetes medications known as SGLT-2 inhibitors, alongside other treatments like semaglutide or insulin. SGLT-2 inhibitors work by helping the kidneys remove extra sugar from the body through urine. Researchers have noticed that these tablets seem to offer special benefits for the heart, but they want to understand exactly how they affect the heart's nervous system.
This clinical trial is designed to see whether taking an SGLT-2 inhibitor for six months can improve nerve control over the heart. By checking how heart rate naturally varies from beat to beat and seeing how well blood sugar stays in a healthy range, researchers hope to discover whether these medicines can slow down or even improve nerve damage around the heart.
Key takeaways
- The study tests whether SGLT-2 inhibitor medicines can protect the nerves that manage your heart rate.
- It is open to adults aged 18 and older living with type 2 diabetes.
- Participation lasts for six months and involves heart monitoring and wearable blood sugar sensors.
- All tests are non-invasive, safe, and designed to track your nerve and heart health closely.
- Taking part is completely voluntary and will not affect your regular medical care.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with type 2 diabetes. Men and women can both take part, regardless of how long they have had the condition.
Participants will generally be people who are already taking, or are suitable to start, standard diabetes medicines. These may include daily tablets such as SGLT-2 inhibitors, DPP-4 inhibitors, or injectable treatments like insulin or GLP-1 medicines.
Because safety is always the top priority, people with certain severe health problems, very poor kidney function, or specific allergies to the study medicines might not be able to join. The study doctor will check your full medical history and current prescriptions to make sure the trial is safe and appropriate 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.
- I am aged 18 or older.
- I have been diagnosed with type 2 diabetes.
- I am willing to attend clinic visits over a six-month period.
- I am comfortable wearing a small blood glucose sensor on my skin for short periods.
- I am happy to undergo painless heart rate and breathing tests.
What does participation involve?
If you take part, your involvement will last for about six months. You will be asked to attend clinic appointments at the start of the study and again at the six-month mark, with occasional check-ins along the way. During these visits, doctors will perform simple, non-invasive heart reflex tests. These involve measuring your pulse and blood pressure while you rest, breathe deeply, or change positions.
You will also wear a small continuous glucose sensor on your skin for about two weeks at a time to monitor your day-to-day sugar levels. In addition, you may have a meal test, where you drink a special nutritional shake and have blood samples taken over a couple of hours to see how your body produces insulin. You will take your prescribed diabetes medications as directed by the medical team throughout the study.
Potential risks and benefits
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Common questions
What is an SGLT-2 inhibitor?
It is a type of modern diabetes tablet that helps lower your blood sugar by removing excess glucose through your urine.
What is heart nerve damage in diabetes?
Over time, high blood sugar can irritate the nerves that control your heartbeat and blood pressure without you thinking about it. This trial looks at ways to protect those nerves.
Are the heart tests painful?
No. The tests are completely painless and non-invasive. They usually involve simple tasks like breathing deeply while your heart rate and blood pressure are monitored.
Will I have to stop taking my current diabetes medicines?
No, you should never stop your medicines on your own. The study doctors will review what you currently take and carefully manage any changes to keep your blood sugar safe.
Do I have to pay to take part?
No. Clinical trials in the UK do not charge participants, and study-related tests or medications are provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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