Study on Metyrapone for Patients with Mild Autonomous Cortisol Secretion

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What is this study about?

This clinical trial is focused on studying a condition known as mild autonomous cortisol secretion, which involves the body producing too much of a hormone called cortisol. The treatment being tested in this study is a medication called Metycor, which contains the active substance metyrapone. Metyrapone works by inhibiting an enzyme in the adrenal gland, which helps reduce the production of cortisol.

The purpose of the study is to assess whether treatment with Metycor can improve certain health conditions related to excess cortisol, such as high blood pressure, issues with blood sugar levels, and overall cortisol levels. Participants in the study will take Metycor for a period of six months. During this time, their health will be monitored to see if there are improvements in these areas.

Throughout the study, participants will have their blood pressure and blood sugar levels checked, and their cortisol levels will be measured. The study will also look at other health factors, such as weight, cholesterol levels, and quality of life. The goal is to determine if Metycor can help manage the symptoms associated with mild autonomous cortisol secretion and improve the overall health of the participants.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical condition.

Informed consent is obtained, ensuring understanding and agreement to participate in the study.

2 initial assessment

An initial assessment is conducted to evaluate current health status, including blood pressure, glucose levels, and cortisol levels.

Baseline measurements are taken for future comparison.

3 medication administration

The medication Metycor is administered in the form of 250 mg soft capsules.

The medication is taken orally as prescribed by the study protocol.

4 treatment period

The treatment period lasts for 6 months, during which the medication is taken regularly.

Regular follow-up visits are scheduled to monitor progress and adjust treatment if necessary.

5 midpoint evaluation

At 3 months, an evaluation is conducted to assess changes in health indicators such as BMI and blood pressure.

Adjustments to the treatment plan may be made based on these results.

6 final assessment

At the end of the 6-month treatment period, a comprehensive assessment is conducted.

This includes measuring cortisol levels, blood pressure, glucose control, weight, and quality of life.

7 outcome evaluation

The primary outcomes are evaluated, including reductions in cortisol levels, blood pressure, and improvements in glucose control.

Secondary outcomes such as weight reduction, bone health, cholesterol levels, and quality of life are also assessed.

Who Can Join the Study?

Must be at least 18 years old.
Patients with ACS (Mild autonomous cortisol secretion) and one or more complications related to metabolism, bones, or mental health.
The patient is eligible for surgical treatment with adrenalectomy (a surgery to remove one or both adrenal glands).
Signed informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH GCP (International Council for Harmonisation Good Clinical Practice) and national/local regulations.

Who Cannot Join the Study?

Patients with severe health conditions that are not stable.
Individuals who are pregnant or breastfeeding.
People who have participated in another clinical trial recently.
Patients with allergies to the study medication.
Individuals with a history of drug or alcohol abuse.
People with mental health conditions that might affect their ability to participate.
Patients who are unable to follow the study procedures.
Individuals with certain medical conditions that the study doctor thinks might interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
St. Olavs Hospital HF	Trondheim	Norway
Hhtwa Bydjyj Hy	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Metyrapone

Metycor is a medication being studied to see if it can help improve conditions related to autonomous cortisol secretion. The trial aims to find out if Metycor can help manage high blood pressure, improve how the body processes sugar, and regulate cortisol levels in patients. The study will observe these effects over a period of six months to determine if Metycor is effective in selecting patients who might benefit from adrenal gland surgery.

Investigated diseases:

Mild autonomous cortisol secretion – This condition involves the excessive production of cortisol by the adrenal glands without the usual regulatory control by the pituitary gland. It is often discovered incidentally during imaging tests for other conditions. Individuals with this condition may not exhibit the classic symptoms of Cushing’s syndrome but can experience subtle signs such as high blood pressure, changes in glucose metabolism, and weight gain. Over time, the excess cortisol can lead to metabolic disturbances, including insulin resistance and hypertension. The progression of the condition can vary, with some individuals remaining stable while others may develop more pronounced symptoms. Regular monitoring of cortisol levels and associated metabolic parameters is important in managing the condition.

Trial ID:

2024-514143-28-00

Protocol code:

2024-514143-28-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Metyrapone for Patients with Mild Autonomous Cortisol Secretion

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?