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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Investigating cardiometabolic risk factors and changes in chronobiology patterns in patients with autonomous adrenal cortisol secretion

This study is investigating a common but mild condition called 'autonomous adrenal cortisol secretion,' where your adrenal glands make a little too much stress hormone (cortisol) on their own. We want to understand how this extra cortisol might affect your heart health, particularly looking at fat around your organs like the liver and heart. We are also exploring how a specific drug, metyrapone, might help by reducing the body's cortisol levels and in turn improve these health markers. The research involves careful checks of things like liver fat with special scans, how your body uses sugar, your body composition, and heart function. This is a later-stage study, meaning the drug is already known to be safe.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Medical University Of Vienna
Enrolment target
50
Start
14 Oct 2024

What is this study about?

This study is designed to understand more about a condition called 'mild autonomous cortisol secretion.' This is when your adrenal glands, which sit on top of your kidneys, produce a slightly higher amount of a hormone called cortisol than they should, without needing a signal from your brain. This extra cortisol can affect different parts of your body over time, especially your metabolism – how your body uses energy – and your heart health.

We want to see how this mild excess cortisol impacts things like the amount of fat in your liver and around your heart, how your body handles sugar (blood glucose), and your overall body composition. The study also aims to evaluate if a medication called metyrapone can help improve these health markers. Metyrapone works by reducing the amount of cortisol your body makes. By taking part, you would help us learn if this treatment could benefit people with this condition.

Understanding these connections is important because it could lead to better ways to manage the condition and prevent potential health problems linked to it. This particular study is in a later stage (often called Phase IV), which means the medication being looked at is already approved for other uses, and we're now studying its effects in more detail for this specific condition.

Key takeaways

  • Study looks at how mild excess cortisol affects health.
  • Investigates a specific medication (metyrapone) for this condition.
  • Focuses on heart health, liver fat, and how your body uses sugar.
  • Participants will receive the study medication and regular health checks.
  • You must be an adult with a diagnosed mild adrenal condition to join.
  • This is a later-stage study on a known medication.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

The main requirement is that you have a specific condition called 'mild autonomous cortisol secretion.' This means your adrenal glands, which are small glands above your kidneys, are making a little too much of the stress hormone cortisol on their own, and it's linked to something called an adrenal adenoma, which is usually a harmless growth on your adrenal gland.

Your doctors will do some tests to confirm you meet the specific health criteria for this condition before you can be considered for the study. They will also check if there are any other health reasons that might prevent you from taking part safely.

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.

  1. Are you an adult (18 years or older)?
  2. Have you been told you have 'mild autonomous cortisol secretion'?
  3. Is your condition linked to an 'adrenal adenoma' (a growth on the adrenal gland)?
  4. Are you able to attend study visits and follow instructions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given a medication called metyrapone, provided as 250mg soft capsules. This study looks at the effects of this medication in real-world use. You will have several appointments where doctors will perform various checks. This will include special scans to measure fat in your liver and around your organs like the heart, using a technique called 1H magnetic resonance spectroscopy.

They will also take measurements of your blood pressure over 24 hours, check your blood for how your body handles sugar and fats, and analyze markers of inflammation. You will also have assessments of your heart function and body composition. The study involves regular follow-up appointments to monitor your health and the effects of the medication. The total duration of your participation will be explained by the study team, along with how often and how many visits will be needed.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would receive close medical monitoring and the medication being investigated, which might improve your health markers related to your condition. There could also be a benefit in helping medical science better understand and treat this condition for others in the future. Potential risks might include side effects from the medication, though metyrapone is a known drug. There could also be discomfort from assessments like blood tests or scans. The study team will explain all known risks to you in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What are adrenal glands?

They are small glands on top of your kidneys that make important hormones like cortisol, which helps your body deal with stress.

What does 'mild autonomous cortisol secretion' mean?

It means your adrenal glands are making a little too much cortisol on their own, even when they shouldn't be.

What is metyrapone?

It's a medication that helps lower the amount of cortisol your body produces.

What is 'liver fat' and why is it important?

Too much fat in the liver can be a sign of poor metabolic health and can lead to other health problems.

Will I get paid to join the study?

Most studies don't pay participants, but they may cover travel costs. You'll need to ask the study team directly.

How to find out more

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

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