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Study on the Effects of Pegvisomant and Somatropin on Liver Fat Metabolism in Patients with Acromegaly and Healthy Individuals

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What is this study about?

This clinical trial is focused on studying the effects of growth hormone on liver fat metabolism in humans. The study involves two groups of participants: those with acromegaly, a condition where the body produces too much growth hormone, and healthy individuals. The treatment being tested includes two medications: SOMAVERT, which contains the active substance pegvisomant, and Genotropin, which contains somatropin. Both medications are administered as a solution for injection under the skin.

The purpose of the study is to understand how growth hormone affects the liver’s ability to process fats and energy. Participants will receive either the medication or a placebo, and the study will observe changes in the body’s energy use, liver fat content, and the production of certain types of fat in the liver. The study will also look at how these changes affect overall body composition and energy expenditure.

Participants will be involved in the study for a short period, during which they will receive injections and undergo various assessments to monitor the effects of the treatment. The study aims to provide insights into how growth hormone influences liver function and fat metabolism, which could have implications for treating conditions related to growth hormone levels.

1 joining the study

Upon joining the study, participants will be informed about the purpose and procedures involved. The study aims to understand the role of growth hormone in liver fat metabolism in humans.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes checking age, which should be between 18 and 70 years, and for healthy volunteers, ensuring plasma triglycerides are less than 300 mg/dl and that they are male.

3 medication administration

Participants will receive medications through subcutaneous injection. The medications used are pegvisomant and somatropin. The specific dosage, frequency, and duration of administration will be explained during the study.

4 monitoring and follow-up

Throughout the study, participants will be monitored for changes in energy metabolism, liver fat content, and other related factors. This includes observing changes in VLDL secretion and de novo lipogenesis, which is the body’s process of creating fat from other substances.

5 completion of the study

The study is expected to end by January 3, 2025. Participants will be informed about the outcomes related to the role of growth hormone in liver fat metabolism.

Who Can Join the Study?

  • Age between 18 and 70 years
  • For healthy volunteers: Plasma triglycerides (a type of fat found in your blood) must be less than 300 mg/dl
  • For healthy volunteers: Must be male

Who Cannot Join the Study?

  • People with a condition called acromegaly cannot participate. This is a condition where the body produces too much growth hormone, leading to enlarged bones and tissues.
  • Only healthy individuals can participate. This means you should not have any ongoing medical conditions.
  • Participants must be within a certain age range. If you are too young or too old, you may not be eligible.
  • Both men and women can participate, but certain health conditions specific to gender may exclude you.
  • Individuals who are considered part of a vulnerable population are not eligible. This includes groups who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.11.2024

Trial locations

Investigated drugs:

Growth Hormone (GH) is a natural substance produced by the body that helps with growth and development. In this clinical trial, it is being studied to understand how it affects the way the liver processes fats. Researchers are interested in seeing if GH can change how the liver releases certain types of fat into the blood and how it influences the body’s energy use. This could help us learn more about how GH affects liver health and fat metabolism in healthy people.

Investigated diseases:

Acromegaly – Acromegaly is a hormonal disorder that develops when the pituitary gland produces excess growth hormone. This overproduction typically occurs in middle-aged adults. The condition leads to the enlargement of bones and tissues, most noticeably in the hands, feet, and face. Over time, individuals may experience joint pain, thickened skin, and enlarged organs. The progression is usually slow, making early changes hard to detect. If left unchecked, it can lead to complications affecting various body systems.

Trial ID:
2024-518214-11-01
Trial Phase:
Therapeutic exploratory (Phase II)

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