Exercise programs for men with metabolic syndrome and low testosterone
Physical Exercise as a Sustainability Tool in Men Affected With Metabolic Syndrome-related Late-onset Central Hypogonadism: Role of Endocrine-metabolic and Neurovegetative Outcomes
This study is testing different exercise programs to see which one helps men with low testosterone and metabolic syndrome improve their health the most.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06094036 on ClinicalTrials.gov |
What this trial studies
This project aims to develop sustainable physical exercise programs specifically for men diagnosed with late-onset central hypogonadism and metabolic syndrome. Participants will engage in personalized exercise regimens for six months, after which they will be divided into two groups based on their physical activity levels. The study will evaluate the effects of these exercise programs on endocrine-metabolic and neurovegetative outcomes, comparing results between the two groups. The goal is to determine the optimal volume of exercise for improving health in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are men diagnosed with late-onset central hypogonadism and metabolic syndrome.
Not a fit: Patients with organic disorders of the hypothalamus-pituitary axis or those unable to participate in physical activity due to medical contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective exercise interventions that improve hormonal and metabolic health in men with hypogonadism.
How similar studies have performed: Previous studies have shown promising results with exercise interventions in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan
- Istituto Auxologico Italiano IRCCS — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Daniela Lucini, MD, PhD — University of Milan; Istituto Auxologico Italiano, IRCCS
- Study coordinator: Luca Giovanelli, MD
- Email: luca.giovanelli@unimi.it
- Phone: +3902619112808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.