Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

NCT06094036 | Recruiting

• 1 other identifier: 45C202
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism, Male; Metabolic Syndrome; Autonomic Imbalance; Life Style, Healthy; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• change in hypothalamic-pituitary-gonadal axis function

  particularly testosterone levels (nmol/l)

  6 months

Secondary Outcomes (16)

• Change in body composition

  6 months

• Change in serum skeletal isoenzyme of alkaline phosphatase

  6 months

• Change in C-terminal telopeptide of type I collagen

  6 months

• Change in erythrocyte sedimentation rate

  6 months

• Change in C-reactive protein

  6 months

Study Arms (2)

weekly physical activity volume performed above 600 MET·minutes/week

OTHER

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

weekly physical activity volume performed below 600 MET·minutes/week

OTHER

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

Interventions

Structured and personalized program of physical exercise BEHAVIORAL

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.

weekly physical activity volume performed above 600 MET·minutes/week; weekly physical activity volume performed below 600 MET·minutes/week

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Eunuchism; Metabolic Syndrome; Sedentary Behavior

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Daniela Lucini, MD, PhD

  University of Milan; Istituto Auxologico Italiano, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Giovanelli, MD

CONTACT

+3902619112808; luca.giovanelli@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 23, 2023
• Study Start: January 11, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

IT (1)