Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Not Applicable

Recruiting

• Conditions: Hypogonadism, Male; Metabolic Syndrome; Autonomic Imbalance; Physical Inactivity; Life Style, Healthy
• Interventions: Behavioral: Structured and personalized program of physical exercise

• Registration Number: NCT06094036
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
weekly physical activity volume performed above 600 MET·minutes/week	Structured and personalized program of physical exercise	Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
weekly physical activity volume performed below 600 MET·minutes/week	Structured and personalized program of physical exercise	Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.

Primary Outcome Measures

Name	Time	Method
change in hypothalamic-pituitary-gonadal axis function	6 months	particularly testosterone levels (nmol/l)

Secondary Outcome Measures

Name	Time	Method
Change in erythrocyte sedimentation rate	6 months	Change in erythrocyte sedimentation rate (mm/h)
Change in C-reactive protein	6 months	Change in C-reactive protein concentration (mg/l)
Change in glucose profile	6 months	glycemia (mg/dl)
Change in nutrition quality	6 months	American Heart Association (AHA) Diet Score
Change in kidney function	6 months	creatinine (mg/dl)
Change in total cholesterol	6 months	Change in total cholesterol concentration (mg/dl)
Change in HDL cholesterol	6 months	Change in HDL cholesterol concentration (mg/dl)
Change in alanine aminotransferase	6 months	Change in alanine aminotransferase concentration (U/L)
Change in perception of stress, fatigue, and somatic symptoms	6 months	short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40)
Change in body composition	6 months	percentage of fat mass and free fat mass
Change in serum skeletal isoenzyme of alkaline phosphatase	6 months	Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l)
Change in C-terminal telopeptide of type I collagen	6 months	Change in C-terminal telopeptide of type I collagen concentration (ng/l)
Change in triglycerides	6 months	Change in triglycerides concentration (mg/dl)
Change in aspartate aminotransferase	6 months	Change in aspartate aminotransferase concentration (U/L)
Change in cardiac autonomic regulation	6 months	Autonomic Nervous System Index (ANSI)
Change in weekly physical activity volume	6 months	short version of International Physical Activity Questionnaire, which focuses on intensity (nominally estimated in Metabolic Equivalents - MET - according to the type of activity) and duration (in minutes) of physical activity. The following levels will be considered: brisk walking (≈ 3.3 METs), other modalities of activity of moderate intensity (≈ 4.0 METs), and activities of vigorous intensity (≈ 8.0 METs).

Trial Locations

Locations (1)

Istituto Auxologico Italiano IRCCS; 🇮🇹 Milan, Italy