Clinical trial NCT06094036: Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism
Official title: Physical Exercise as a Sustainability Tool in Men Affected With Metabolic Syndrome-related Late-onset Central Hypogonadism: Role of Endocrine-metabolic and Neurovegetative Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypogonadism, Male
Metabolic Syndrome
Autonomic Imbalance
Life Style, Healthy
Physical Inactivity
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: change in hypothalamic-pituitary-gonadal axis function
timeFrame: 6 months
Secondary outcomes:
measure: Change in body composition
timeFrame: 6 months
measure: Change in serum skeletal isoenzyme of alkaline phosphatase
timeFrame: 6 months
measure: Change in C-terminal telopeptide of type I collagen
timeFrame: 6 months
measure: Change in erythrocyte sedimentation rate
timeFrame: 6 months
measure: Change in C-reactive protein
timeFrame: 6 months
measure: Change in total cholesterol
timeFrame: 6 months
measure: Change in HDL cholesterol
timeFrame: 6 months
measure: Change in triglycerides
timeFrame: 6 months
measure: Change in glucose profile
timeFrame: 6 months
measure: Change in kidney function
timeFrame: 6 months
measure: Change in aspartate aminotransferase
timeFrame: 6 months
measure: Change in alanine aminotransferase
timeFrame: 6 months
measure: Change in cardiac autonomic regulation
timeFrame: 6 months
measure: Change in nutrition quality
timeFrame: 6 months
measure: Change in perception of stress, fatigue, and somatic symptoms
timeFrame: 6 months
measure: Change in weekly physical activity volume
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
affiliation: University of Milan; Istituto Auxologico Italiano, IRCCS
name: Daniela Lucini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: