Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Insulin Resistance and Statin Treatment in Renal Transplant Recipients and Patients with Chronic Kidney Disease

This study is investigating a common health issue called 'insulin resistance' in two groups of people: those who have received a kidney transplant and those living with chronic kidney disease. Insulin resistance means your body doesn't use insulin properly to control blood sugar, which can lead to other health problems. The researchers want to see if a cholesterol-lowering medicine called pravastatin, which is often prescribed, affects how the body uses sugar. They will also compare it to a 'dummy' tablet (placebo). The aim is to better understand how these treatments impact sugar control in these specific patient groups.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Aarhus University Hospital

Enrolment target

Start

26 Sep 2022

Insulin resistance

What is this study about?

Imagine your body needs sugar for energy, and insulin is like a key that lets sugar into your cells. If you have 'insulin resistance,' it's like the key isn't working very well, so sugar builds up in your blood. This is a common problem, especially for people with kidney conditions or after a kidney transplant.

Doctors sometimes prescribe medicines called 'statins' to lower cholesterol, like pravastatin in this study. What we don't fully understand is how these statins might also affect how well your body uses sugar, especially for people with kidney issues. This study aims to find out if pravastatin can change how effective insulin is in these patients.

To do this, the study will compare pravastatin with a 'placebo' – which looks like the real medicine but doesn't contain any active drug. This helps the researchers see if any changes are truly due to the pravastatin or something else. Understanding this could help doctors make better choices about treatments for people with kidney problems.

Key takeaways

This study investigates how certain medicines affect sugar control.
It focuses on people with kidney disease or kidney transplants.
The study is exploring the effects of a common cholesterol medicine (pravastatin).
It will compare pravastatin to a dummy pill (placebo).
The goal is to improve understanding for future patient care.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

Crucially, you would need to be in one of two specific groups: either you have had a kidney transplant, or you have ongoing kidney problems, known as chronic kidney disease.

The researchers are specifically interested in people in these groups who are also experiencing 'insulin resistance,' which means your body isn't processing sugar as efficiently as it should.

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?
Have you had a kidney transplant?
Or do you have ongoing kidney problems (chronic kidney disease)?
Have you been told you have insulin resistance?
Are you able to attend study visits and tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will likely have several visits to a clinic. During these visits, the research team will do special tests to measure how your body uses insulin and controls sugar. One key test is called a 'hyperinsulinemic euglycemic glucose clamp,' which helps them get a very accurate picture of your insulin sensitivity.

You would be given either the study medicine, pravastatin, or a dummy tablet (placebo), following a set schedule. You might also have blood tests to check your sugar and other health markers. The study will involve carefully monitoring your health and sugar levels over a period of time, and the total duration would be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could help us learn more about how medicines affect sugar control in people with kidney conditions, which might benefit future patients. You might also receive closer monitoring of your health than usual. However, there's no guarantee of direct personal benefit. Potential risks could include side effects from the study medication, though doctors will monitor you closely for these. There's also the chance of discomfort from tests like blood draws. You are free to withdraw from the study at any time without giving a reason, and it will not affect your usual 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
Denmark

Common questions

What is insulin resistance?

It means your body doesn't use insulin well to manage sugar, so sugar can build up in your blood.

What is pravastatin?

It's a common medicine often used to lower cholesterol levels in the blood.

Will I definitely get the active medicine?

Some participants will receive pravastatin, while others will receive a 'dummy' tablet called a placebo.

Why are they studying people with kidney conditions?

People with kidney transplants or chronic kidney disease often have insulin resistance, and the study wants to understand how pravastatin affects this in them.

What is a 'glucose clamp' test?

It's a special, accurate test used in research to see exactly how well your body uses insulin to control blood sugar.