RecruitingNAINTERVENTIONAL

Ultradian Steroid Rhythms in Adrenal Incidentalomas

This study is about small lumps on the adrenal glands, called adrenal incidentalomas, which are often found by chance. Some of these lumps can produce slightly too much of a hormone called cortisol, a condition known as mild autonomous cortisol secretion (MACS). While many lumps are harmless, MACS can affect your heart and overall health. Standard tests don't always give a full picture of how cortisol levels change. This research uses a new system to regularly check cortisol and other hormone levels over 24-48 hours. By comparing people with MACS to those with harmless lumps, researchers hope to discover specific daily patterns that could lead to better ways to diagnose MACS and improve how it's treated.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

15 Apr 2026

Estimated completion

01 Oct 2027

Mild Autonomous Cortisol Secretion Adenoma Non Secreting Adenoma

What is this study about?

Imagine your adrenal glands, which sit on top of your kidneys, are like tiny factories that produce important hormones, including cortisol. Sometimes, doctors accidentally find small lumps on these glands during scans, which are called adrenal incidentalomas. Most of the time, these lumps are harmless and don't cause any problems. However, in about three out of every ten people, these lumps can produce slightly more cortisol than needed. This is a condition called Mild Autonomous Cortisol Secretion, or MACS.

Even though the extra cortisol in MACS is only a little bit, it can still gently upset your body's balance. This mild imbalance might increase the risk of heart problems and other health issues over time. Currently, it's a bit tricky for doctors to get a really clear picture of how these hormone levels behave throughout a whole day. Standard tests might miss important shifts because they only take a few samples.

This study uses an innovative new method, called the U-RYTHM system, to get a much more detailed view. It involves taking tiny fluid samples just under the skin every 20 minutes for a day or two. By doing this, researchers can build a complete timeline of how cortisol and other related hormones change over 24 hours. They will compare these detailed patterns in people with MACS to those with harmless adrenal lumps. This will help them understand if there are specific times of day when cortisol levels are unusually high in MACS, which could be key to better diagnosing and treating the condition in the future.

Key takeaways

The study investigates hormone patterns in adrenal gland lumps.
It focuses on 'Mild Autonomous Cortisol Secretion' (MACS) and harmless lumps.
A new system (U-RYTHM) tracks hormone levels every 20 minutes for 1-2 days.
The goal is to improve diagnosis and treatment for MACS.
Your hormone data could help many future patients.
Participation involves frequent, small fluid samples from under the skin.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old. You should have been found to have one or more lumps on your adrenal gland during a scan, known as adrenal incidentalomas. You must also be eligible for the UK's social security system.

If you have MACS, your blood tests after certain medications will show specific cortisol levels (above 50 nmol/L) and low ACTH levels. If you have a non-secreting lump (meaning it doesn't produce extra hormones), your cortisol levels after the same medication will be 50 nmol/L or less.

Unfortunately, you can't join if you are under 18, pregnant or breastfeeding, or taking certain medications like oral estrogens (you'd need to stop them for at least 6 weeks before the study). You also can't participate if you have known adrenal problems, are already taking steroids, are part of another study, or are legally unable to give consent.

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 between 18 and 85 years old?
Have you been told you have an adrenal lump that appeared incidentally on a scan?
Are you currently pregnant or breastfeeding?
Are you taking oral oestrogen medication (or have you within the last 6 weeks)?
Are you currently receiving treatment or medication for another adrenal gland problem?
Are you taking part in another clinical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have tiny samples of fluid taken from just under your skin, every 20 minutes for a full 24 to 48 hours. This is done using a special U-RYTHM system. These samples will help researchers understand how your hormone levels change throughout the day. There won't be any specific medications given as part of this study, beyond what you might already be taking. The total duration of active participation for collecting samples will be 1 to 2 days.

Potential risks and benefits

Participating in this study might not directly benefit your health immediately, but it could greatly help doctors in the future to better understand and treat MACS, potentially improving care for many others. The main risk involves the sampling process, which is designed to be minimally invasive. You might experience some mild discomfort or bruising where the samples are taken, similar to a small pinprick. There are no known major risks associated with the U-RYTHM system itself. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

Hôpital Haut-Levêque
Verified postcode
Pessac, France· Recruiting

Common questions

What is an adrenal incidentaloma?

It's a small lump found on your adrenal gland during a scan for another reason, often harmless.

What is MACS?

MACS stands for 'Mild Autonomous Cortisol Secretion,' meaning your adrenal lump is making slightly too much cortisol.

How is this study different from normal tests?

This study takes very frequent hormone samples over a day or two, giving a much more detailed picture than typical one-off blood tests.

Will I get medication in this study?

No, this study focuses on monitoring your hormone levels, not on giving new medications.

Is the sampling painful?

The sampling involves tiny, frequent pinpricks to collect fluid from just under your skin, which may cause mild discomfort.

How to find out more

Amandine FERRIERE, Dr

amandine.ferriere@chu-bordeaux.fr 05 57 57 64 24 Official trial record

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