Clinical trials on Metabolic Disease

  • CT-EU-00114461

    Understanding the Impact of Androgen Blockade on Metabolism in PCOS

    The REFUEL PCOS Study 2 is a research project focused on understanding how high levels of male hormones, like testosterone, affect the way women with Polycystic Ovary Syndrome (PCOS) use energy in their muscles. PCOS is a condition that affects about 10% of women and can lead to problems like diabetes, liver disease, high blood pressure, and heart disease. This study is particularly interested in how these hormones might change the balance of energy in the muscles, which could lead to these health issues.

    During the study, participants will undergo detailed tests to check their metabolism, including blood tests and muscle biopsies, both before and after they take a medication called Bicalutamide for 28 days. This medication blocks the action of testosterone. The study will also use a special technique to see how participants break down fat and other nutrients after eating a breakfast meal, by looking at markers in their blood and breath.

    The main goal of the study is to see how blocking testosterone affects the way the body and muscles handle energy in women with PCOS who have high levels of androgens. This could help us understand more about the link between hormone imbalances and metabolic diseases in women with PCOS.

    If you’re interested in participating, you’ll be asked to come in for two study visits. After the first visit, you’ll start taking Bicalutamide 50 mg daily for 28 days, and then you’ll have another visit to see if there have been any changes in your metabolism.

    This research could lead to better ways to manage or treat the metabolic risks associated with PCOS, addressing a major concern for many affected by the condition.

    • Bicalutamide
  • Understanding Female Metabolic Health: The FEMAIL Study on Androgens and Risk of Diabetes

    The FEmale Metabolic Risk and Androgens: an Irish Longitudinal (FEMAIL) Study is a research project focused on understanding how certain hormones, known as androgens, affect women’s health, particularly in relation to metabolic diseases like diabetes. Androgens are typically considered male hormones, but they also play a significant role in women’s bodies. This study is particularly interested in a new class of androgens called 11-oxygenated androgens, which have been found to be the main type of androgens in women, including those with a condition called polycystic ovary syndrome (PCOS). PCOS affects about 10% of women and is linked to higher levels of androgens and a risk of developing diabetes.

    The study aims to explore how these 11-oxygenated androgens, especially one called 11-ketotestosterone (11KT), relate to the risk of developing type 2 diabetes and other metabolic issues. Unlike other androgens, 11-oxygenated androgens do not decrease with age, which could mean they influence the risk of diabetes in women throughout their lives.

    Participants in the study will undergo a thorough health assessment, including a questionnaire about their medical history and lifestyle, measurements of their body composition, and tests of their blood, urine, and saliva. These tests will help the researchers understand the participants’ hormone levels, metabolic health, and overall well-being. The study will also include a muscle biopsy, a procedure to collect a small sample of muscle tissue, to get a closer look at how these hormones affect muscle and metabolic health.

    The FEMAIL Study is being conducted by a team of researchers in Ireland and is looking for participants through local advertising in Beaumont Hospital and RCSI Medical School. This research could lead to better understanding of how androgens affect women’s risk of metabolic diseases and potentially uncover new ways to predict and prevent these conditions.

    If you’re interested in learning more about your metabolic health and contributing to important research that could benefit women’s health in the future, this study might be a great opportunity.