Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism (ExLOH)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Giovanelli, MD; Phone Number: +3902619112808; Email: luca.giovanelli@unimi.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Istituto Auxologico Italiano IRCCS
    • Contact: Luca Giovanelli; Phone Number: +3902619112808; Email: luca.giovanelli@unimi.it
    • Principal Investigator: Daniela Lucini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Structured and personalized program of physical exercise; In line with the most recent guidelines, exercise prescription will require the clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals. This intervention will be accompanied by a nutrition program aiming for proper dietary habits in terms of both quantity and quality.
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.	Behavioral: Structured and personalized program of physical exercise; In line with the most recent guidelines, exercise prescription will require the clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals. This intervention will be accompanied by a nutrition program aiming for proper dietary habits in terms of both quantity and quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in hypothalamic-pituitary-gonadal axis function	particularly testosterone levels (nmol/l)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body composition	percentage of fat mass and free fat mass	6 months
Change in serum skeletal isoenzyme of alkaline phosphatase	Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l)	6 months
Change in C-terminal telopeptide of type I collagen	Change in C-terminal telopeptide of type I collagen concentration (ng/l)	6 months
Change in erythrocyte sedimentation rate	Change in erythrocyte sedimentation rate (mm/h)	6 months
Change in C-reactive protein	Change in C-reactive protein concentration (mg/l)	6 months
Change in total cholesterol	Change in total cholesterol concentration (mg/dl)	6 months
Change in HDL cholesterol	Change in HDL cholesterol concentration (mg/dl)	6 months
Change in triglycerides	Change in triglycerides concentration (mg/dl)	6 months
Change in glucose profile	glycemia (mg/dl)	6 months
Change in kidney function	creatinine (mg/dl)	6 months
Change in aspartate aminotransferase	Change in aspartate aminotransferase concentration (U/L)	6 months
Change in alanine aminotransferase	Change in alanine aminotransferase concentration (U/L)	6 months
Change in cardiac autonomic regulation	Autonomic Nervous System Index (ANSI)	6 months
Change in nutrition quality	American Heart Association (AHA) Diet Score	6 months
Change in perception of stress, fatigue, and somatic symptoms	short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40)	6 months
Change in weekly physical activity volume	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).	6 months

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Daniela Lucini, MD, PhD, University of Milan; Istituto Auxologico Italiano, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Gonadal Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Hypogonadism; Eunuchism
• Other Study ID Numbers: 45C202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No