Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Launched by ISTITUTO AUXOLOGICO ITALIANO · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how physical exercise can help men who have a specific condition called late-onset central hypogonadism, which is often linked with metabolic syndrome. Metabolic syndrome includes health issues like high blood pressure and high blood sugar, and it can affect energy levels and sexual health. The goal of the study is to create personalized exercise programs for participants and see how these programs impact their hormone levels and overall health over six months. After this period, participants will be divided into two groups based on how much exercise they’ve been doing, and changes in their health will be compared.

To be eligible for this study, men need to have been diagnosed with late-onset central hypogonadism and metabolic syndrome, meaning they have specific symptoms and health measurements that meet the criteria. Participants should be able to give their informed consent and be willing to commit to the exercise program. Throughout the study, participants can expect to engage in a tailored exercise routine and receive support in tracking their health improvements. It's important to note that individuals with certain medical conditions, like heart issues or severe mental health disorders, may not be able to participate.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • diagnosis of late-onset central hypogonadism: total T levels \< 8 nmol/L (or \< 12 nmol/L in the presence of calculated free T \< 225 pmol/L) combined with sexual symptoms (erectile dysfunction, low libido and loss of waking erections) \[12\];
• • diagnosis of metabolic syndrome, defined as association of waist circumference (WC) \> 94 cm and at least two among the following criteria: triglycerides ≥ 150 mg/dl, HDL-C \< 40 mg/dl, glucose \> 100 mg/dl, blood pressure (BP) ≥ 130/85 mmHg \[33\];
• • ability to give informed consent, in accordance with good clinical practice rules and applicable national laws.
• Exclusion Criteria:
• • History of hypothalamus-pituitary organic disorders and/or testicular diseases;
• • impossibility to assess cardiac autonomic regulation due to arrhythmias and/or current treatment for heart rate (HR) control (e.g., beta-blockers, antiarrhythmics);
• • impossibility to undergo clinical assessment;
• • impossibility or contraindications to perform exercise program (for instance, psychiatric disorders, severe musculoskeletal diseases, arrhythmias);
• • inability to give informed consent or unwillingness to be enrolled in the study.