Status:
RECRUITING
Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism
Lead Sponsor:
Istituto Auxologico Italiano
Conditions:
Hypogonadism, Male
Metabolic Syndrome
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
Aim of this project is to delineate sustainable physical exercise programs and to assess the effects of such programs mainly on endocrine-metabolic and neurovegetative outcomes in a cohort of men with...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06094036
Start Date
January 11 2023
End Date
December 31 2024
Last Update
March 12 2024
Active Locations (1)
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1
Istituto Auxologico Italiano IRCCS
Milan, Italy