Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

GLP-1 receptor agonists as preventive treatment of diabetes after renal transplantation: a single-arm interventional clinical trial. Study 2: Patients on the waiting list for kidney transplantation.

This study is investigating if a medication called Trulicity (dulaglutide) can help improve health conditions, particularly early signs of diabetes, in people who are waiting for a kidney transplant. These health issues are often grouped together and called 'metabolic syndrome'. Researchers want to see if Trulicity can help reduce these problems within three to six months. The main goal is to find out if patients can get their metabolic syndrome under control, meaning fewer health risks, especially related to blood sugar levels. This is a Phase 3 study, meaning it's a later stage trial focusing on how well the treatment works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Enrolment target

Start

01 Dec 2023

Metabolic syndrome in patients on the waiting list for kidney transplantation Metabolic syndrome in patients on the waiting list for kidney transplantation

What is this study about?

This research study is looking into a medicine called Trulicity, which might help people who are waiting for a kidney transplant. Many people waiting for a transplant can develop a group of health problems known as 'metabolic syndrome'. This includes things like having blood sugar levels that are a bit too high (often called pre-diabetes), extra weight around the middle (known as tummy fat), and other issues that can increase the risk of developing full-blown type 2 diabetes and heart problems. The study wants to see if Trulicity can help reverse these early signs of metabolic syndrome.

The main aim is to see how many people taking Trulicity manage to get their metabolic syndrome under control within three to six months. 'Under control' means that their risk factors for metabolic syndrome, especially their blood sugar levels, are much improved. The researchers will be checking things like fasting blood sugar and what happens to blood sugar two hours after a sugary drink, to see if pre-diabetes improves. They will also look at how the body handles insulin and how the cells that produce insulin are working.

Ultimately, this study is important because improving these health conditions before a kidney transplant could potentially lead to better outcomes for patients. By understanding if Trulicity can help manage blood sugar and other metabolic issues, doctors might be able to offer better care to people on the transplant waiting list. This could make a big difference to their overall health and reduce risks both before and after their transplant.

Key takeaways

The study explores if Trulicity can improve early signs of diabetes and other health issues (metabolic syndrome) in kidney transplant candidates.
It's for adults aged 18 and over who are on the kidney transplant waiting list and also have metabolic syndrome.
Participants will receive Trulicity injections over six months, with regular health checks.
The main goal is to see if metabolic syndrome, especially blood sugar levels, can be brought under control.
Potential benefits include improved health before transplant; potential risks include side effects like tummy problems or, rarely, very low blood sugar.
You can stop participating at any time without it affecting your medical care.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older, and currently on the waiting list for a kidney transplant.

The study is specifically looking for people who have 'metabolic syndrome'. This means you will have certain health signs like having slightly raised blood sugar levels (pre-diabetes), or other health markers that indicate you're at increased risk of developing diabetes or heart disease. The research team will do tests to confirm if you meet these specific health criteria for metabolic syndrome.

Both men and women can take part in this study. The research team will be able to tell you if you meet all the specific requirements to be included.

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?
Are you currently on the waiting list for a kidney transplant?
Have you been told you have 'metabolic syndrome' or have slightly high blood sugar levels?
Are you able to attend appointments for up to six months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the medicine Trulicity, which is an injection given with a pre-filled pen. You will receive this medicine for a period of six months. During this time, you will have regular visits with the study team.

These visits will involve various checks and tests. The main things they will look at are your blood sugar levels (including blood tests after fasting and after a sugary drink), your weight and waist measurements. They will also check for any side effects you might experience. These assessments will happen at the start of the study, and then again after 3 months and 6 months of taking the medicine. The total duration of active treatment and follow-up for the main study will be six months.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as improving your blood sugar levels and other aspects of metabolic syndrome before your kidney transplant, which might lead to better health outcomes. However, like all medicines, Trulicity can have side effects. Common ones reported in this type of study included tummy upsets like feeling sick or diarrhoea, headaches, or pain where the injection is given. More serious, but rare, side effects included inflammation of the pancreas (pancreatitis) or very low blood sugar. You have the right 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.

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Unverified
Spain

Common questions

What is Trulicity?

Trulicity is a medicine (dulaglutide) that comes in a pre-filled pen and is given as an injection. It's used to help control blood sugar levels.

What is 'metabolic syndrome'?

Metabolic syndrome is a group of health problems like slightly high blood sugar, extra tummy fat, and other issues that can increase your risk of diabetes and heart disease.

Why is this study important for people waiting for a kidney transplant?

This study aims to see if improving these health problems before a kidney transplant can lead to better overall health and outcomes for patients.

How long would I be in the study if I take part?

You would take the medicine and be monitored for about six months.

Will taking part affect my place on the kidney transplant list?

No, your place on the kidney transplant list should not be affected if you choose to take part or if you later decide to leave the study.