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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Istituto Auxologico Italiano IRCCS
RECRUITING
Milan
Contact Information
Primary
Luca Giovanelli, MD
luca.giovanelli@unimi.it
+3902619112808
Time Frame
Start Date: 2023-01-11
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 72
Treatments
Other: weekly physical activity volume performed above 600 MET·minutes/week
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
Other: weekly physical activity volume performed below 600 MET·minutes/week
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
Sponsors
Leads: Istituto Auxologico Italiano

This content was sourced from clinicaltrials.gov