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Study on Metyrapone for Patients with Mild Autonomous Cortisol Secretion Due to Adrenal Adenoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as autonomous adrenal cortisol secretion, which occurs when the adrenal glands produce cortisol without the usual regulation by the body. This condition is often associated with an adrenal adenoma, a non-cancerous tumor in the adrenal gland. The study aims to explore the risk factors related to heart and metabolism health, as well as changes in the body's natural biological rhythms, known as chronobiology, in patients with this condition.

The treatment being investigated in this study is a medication called Metyrapone, which is administered in the form of 250mg soft capsules. Metyrapone is known to affect the production of cortisol, and the study will examine how it influences the health of patients with autonomous adrenal cortisol secretion. Some participants in the study will receive a placebo, which is a substance with no active medication, to compare the effects of Metyrapone.

Throughout the study, participants will take the medication orally and will be monitored for changes in various health indicators. These include the amount of fat in the liver, insulin levels, heart function, and body composition. The study will also look at blood pressure and markers of inflammation in the body. The goal is to better understand how Metyrapone affects these factors in patients with autonomous adrenal cortisol secretion over a period of time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your medical history will be reviewed to confirm eligibility based on specific criteria, such as age and morning cortisol levels.
A physical examination will be conducted, and baseline measurements will be taken, including blood pressure and body composition.
Step 2
Medication administration
You will be provided with Metyrapone HRA 250mg soft capsules to take orally. The dosage and frequency will be determined by the study team based on your specific needs.
The duration of medication administration will be specified by the study protocol, and you will be informed of any changes during the trial.
Step 3
Regular monitoring
Throughout the trial, you will have regular check-ups to monitor your health and the effects of the medication. This includes blood tests to assess insulin secretion and sensitivity, as well as other health parameters.
You may also undergo imaging tests, such as magnetic resonance spectroscopy, to evaluate changes in liver lipid content and other body compositions.
Step 4
Follow-up visits
You will attend follow-up visits at scheduled intervals to discuss your progress and any side effects you may experience.
These visits will also include assessments of heart function, fat mass, and systemic inflammation markers.
Step 5
Final assessment
At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on your health.
This will include a comprehensive review of all collected data and a discussion of the study's findings with you.

Who can join the trial?

5 criteria

Must be over 18 years old.
Must have a history of an adrenal adenoma. An adrenal adenoma is a non-cancerous tumor on the adrenal gland.
For the group with autonomous cortisol secretion:
- Morning cortisol level must be greater than 1.8 micrograms per deciliter (ug/dl) after taking a 1 mg dexamethasone suppression test. This test checks how your body responds to a steroid medicine called dexamethasone.
- Must not have the typical symptoms of Cushing’s syndrome, which is a condition caused by high levels of cortisol.
- For the control group:
  - Morning cortisol level must be less than or equal to 1.8 micrograms per deciliter (ug/dl) after taking a 1 mg dexamethasone suppression test.

Who cannot join the trial?

8 criteria

Patients with serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of substance abuse or alcohol dependency.
Patients who are unable to give consent or understand the study procedures.
Patients with uncontrolled high blood pressure or other heart conditions.
Patients with severe mental health disorders that are not stable.
Patients taking medications that could affect the hypothalamus-pituitary-adrenal (HPA) axis. The HPA axis is a system in the body that controls reactions to stress and regulates many body processes.

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Verified sites

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Verified
Medical University Of Vienna
Vienna, Austria

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Investigated drugs

{ "authorizedApplication.authorizedPartI.products.0": [ { "productName": "Hydrocortisone", "description": "Hydrocortisone is a medication that helps to replace or supplement the natural hormone cortisol in the body. It is often used in conditions where the body does not produce enough cortisol, such as in adrenal insufficiency. In this trial, it is used to study its effects on cardiometabolic risk factors and chronobiology patterns in patients with autonomous adrenal cortisol secretion." }, { "productName": "Metyrapone", "description": "Metyrapone is a medication that reduces the production of cortisol in the body. It is used to help control excessive cortisol levels, which can be a problem in certain medical conditions. In this trial, it is used to understand how lowering cortisol levels affects cardiometabolic risk factors and chronobiology patterns in patients with autonomous adrenal cortisol secretion." } ] }

Metyrapone Bp

What is already known about the treatment

Trade Name of the Medication – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main therapeutic indication is for treating mild autonomous cortisol secretion in patients with adrenal adenoma. At the molecular level, it works by regulating the production of cortisol, a hormone that can affect various body functions. It belongs to the pharmacological class of hormone regulators.

Investigated diseases

Autonomous Cortisol Secretion – This condition occurs when the adrenal glands produce cortisol without the usual regulatory signals from the pituitary gland. It is often associated with adrenal adenomas, which are benign tumors of the adrenal gland. Over time, the excess cortisol can lead to changes in metabolism, affecting how the body processes fats, proteins, and carbohydrates. This can result in increased fat deposition, particularly in the abdominal area, and may alter insulin sensitivity. The condition can also impact cardiovascular health, potentially affecting heart function and blood pressure. Additionally, it may influence the body's inflammatory response, leading to changes in systemic inflammation markers.