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Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism | Clinical Trials | Clareo Health

RECRUITINGNA

Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Physical Exercise as a Sustainability Tool in Men Affected With Metabolic Syndrome-related Late-onset Central Hypogonadism: Role of Endocrine-metabolic and Neurovegetative Outcomes

NCT06094036•Istituto Auxologico Italiano

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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 metabolic syndrome-related late-onset central hypogonadism. Participants will undergo a personalised exercise program. After 6 months they will be subdivided into two groups, according to the weekly physical activity volume actually performed (above or below 600 MET·minutes/week). Changes in endocrine-metabolic and neurovegetative outcomes will be compared between the two groups.

Eligibility

Age

18 - 80 years

Sex

MALE

Healthy Volunteers

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.

Locations (1)

Istituto Auxologico Italiano IRCCS

Milan, Italy

Key Dates

Start Date

January 11, 2023

Primary Completion Date

December 1, 2024

Completion Date

December 31, 2024

Last Updated

March 12, 2024

Enrollment

ESTIMATED participants

Conditions

Hypogonadism, MaleMetabolic SyndromeAutonomic ImbalanceLife Style, HealthyPhysical Inactivity

Interventions

Structured and personalized program of physical exercise

BEHAVIORAL

Contacts

Luca Giovanelli, MD

CONTACT

+3902619112808 luca.giovanelli@unimi.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Inclusion Criteria

Exclusion Criteria

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