Ongoing, recruitingTherapeutic use (Phase IV)Interventional

DiEtary Sodium Intake effects on ertugliflozin-induced changes in GFR, reNal oxygenation and systemic hemodynamics: the DESIGN study, a randomized, placebo-controlled, cross-over study with ertugliflozin in people with type 2 diabetes.

This research, called the DESIGN study, is designed to understand how the amount of salt in your diet can change how a medicine called ertugliflozin (also known as Steglatro) works in people with type 2 diabetes. We want to see if eating the amount of salt recommended by the World Health Organization (WHO) has a different effect on your blood pressure compared to eating a lot of salt. We're testing this in adults with type 2 diabetes who are also overweight or obese. Participants will take either ertugliflozin or a dummy pill (placebo), and we'll look closely at their 24-hour blood pressure readings. This study aims to help us understand the best way to use this medication in combination with dietary choices.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Amsterdam UMC

Enrolment target

Start

03 Oct 2024

Type 2 diabetes

What is this study about?

This study is called the DESIGN study, and it's looking into how a medicine for type 2 diabetes, called ertugliflozin (you might know it as Steglatro), works differently depending on how much salt you eat. We know that both your diet and your medication play a big part in managing type 2 diabetes, especially when it comes to things like blood pressure.

We're particularly interested in people with type 2 diabetes who are overweight or obese. We want to compare what happens when these individuals take ertugliflozin while eating the amount of salt recommended by health experts, versus when they eat a diet higher in salt. We'll also compare this to people who take a dummy pill (placebo) instead of the actual medication. Our main focus is to see how these different combinations affect your blood pressure over a full 24-hour period.

Beyond blood pressure, the study will also look at other important health markers. This includes how well your kidneys are working, your kidney oxygen levels, and other measurements related to your kidney health. We'll also check your blood sugar levels and how much sugar your body gets rid of. The goal is to get a really clear picture of how diet and this medication interact to affect various aspects of your health, particularly your heart and kidneys. This is a "Phase IV" study, which means the drug is already approved and widely used, and this research helps us understand more about its best use in real-world situations.

Key takeaways

The study explores how salt in your diet affects a diabetes drug, ertugliflozin.
It involves adults with type 2 diabetes who are overweight or obese.
A main focus is how diet and ertugliflozin together affect your blood pressure.
Kidney health and other diabetes markers will also be closely monitored.
Participation involves taking medication/placebo and following dietary guidelines.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults with type 2 diabetes. It's important that you are also overweight or obese to take part. Both men and women are welcome to participate.

You should be able to follow a specific diet regarding your salt intake, as this is a key part of the study. Your medical team will carefully check your overall health to make sure this study is suitable 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 an adult aged 18 or over?
Do you have type 2 diabetes?
Are you overweight or obese?
Are you able to follow specific dietary instructions regarding salt intake?
Are you willing to attend regular clinic appointments for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a certain period. During this time, you will receive either the study drug, ertugliflozin (Steglatro), or a dummy pill (placebo). You will also be asked to follow specific dietary guidelines regarding your salt intake, sometimes eating a recommended amount and other times a higher amount. This part of the study is 'cross-over,' meaning you will experience different combinations of diet and medication.

You will need to attend several appointments at the clinic. These visits will involve various tests and checks, such as blood pressure measurements over 24 hours, blood tests, and urine tests. These assessments help the researchers understand how the medication and diet are affecting your body. The study team will explain everything in detail, including how long each visit will take and the total duration of your participation.

Potential risks and benefits

Participating in this study might offer you some benefits, such as close monitoring of your health and potentially gaining a better understanding of how your diet impacts your diabetes management. However, as with any medical study, there are potential risks, including possible side effects from the medication or the inconvenience of attending appointments and following specific dietary plans. The study team will explain all known risks and benefits in detail before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual care.

Locations (1)

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

—
Unverified
Netherlands

Common questions

What is ertugliflozin (Steglatro)?

Ertugliflozin is a medicine used to treat type 2 diabetes. It helps your body get rid of extra sugar through your urine, which can lower your blood sugar levels.

What does 'placebo' mean?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects with what happens when no active drug is given.

Will I have to change my diet?

Yes, a key part of this study involves following specific dietary instructions regarding the amount of salt you eat. The researchers want to see how different salt levels affect the medication.

What does a 'cross-over' study mean?

A cross-over study means you will try both the active drug and the placebo at different times, and you will also experience different salt intake levels. This allows researchers to compare the effects within the same person.

Why are you looking at kidneys?

People with type 2 diabetes can sometimes experience kidney problems. This study is checking how ertugliflozin and different salt intakes affect kidney health and function.