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RecruitingNCT06094036ExLOHUpdated Mar 12, 2024

Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

An interventional study of Structured and personalized program of physical exercise in Hypogonadism, Male, Metabolic Syndrome and Autonomic Imbalance, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Istituto Auxologico Italiano · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Registered 8 months after the study started (first participant enrolled Jan 2023, registered Oct 2023).
  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Hypogonadism, Male
  • Metabolic Syndrome
  • Autonomic Imbalance
  • Life Style, Healthy
  • Physical Inactivity
03

In context

Eunuchism

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's planned enrollment of 72 is above the median of 60 across 55 interventional studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.

Browse Istituto Auxologico Italiano studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , in accordance with good clinical practice rules and applicable national laws.

Exclusion criteria

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 to perform exercise program (for instance, psychiatric disorders, severe musculoskeletal diseases, arrhythmias);
  • inability to give or unwillingness to be enrolled in the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
72 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralStructured 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.

06

What researchers measure

Primary outcomes

  1. change in hypothalamic-pituitary-gonadal axis function

    particularly testosterone levels (nmol/l)

    Time frame: 6 months

Secondary outcomes

  1. Change in body composition

    percentage of fat mass and free fat mass

    Time frame: 6 months

  2. Change in serum skeletal isoenzyme of alkaline phosphatase

    Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l)

    Time frame: 6 months

  3. Change in C-terminal telopeptide of type I collagen

    Change in C-terminal telopeptide of type I collagen concentration (ng/l)

    Time frame: 6 months

  4. Change in erythrocyte sedimentation rate

    Change in erythrocyte sedimentation rate (mm/h)

    Time frame: 6 months

  5. Change in C-reactive protein

    Change in C-reactive protein concentration (mg/l)

    Time frame: 6 months

  6. Change in total cholesterol

    Change in total cholesterol concentration (mg/dl)

    Time frame: 6 months

  7. Change in HDL cholesterol

    Change in HDL cholesterol concentration (mg/dl)

    Time frame: 6 months

  8. Change in triglycerides

    Change in triglycerides concentration (mg/dl)

    Time frame: 6 months

  9. Change in glucose profile

    glycemia (mg/dl)

    Time frame: 6 months

  10. Change in kidney function

    creatinine (mg/dl)

    Time frame: 6 months

  11. Change in aspartate aminotransferase

    Change in aspartate aminotransferase concentration (U/L)

    Time frame: 6 months

  12. Change in alanine aminotransferase

    Change in alanine aminotransferase concentration (U/L)

    Time frame: 6 months

  13. Change in cardiac autonomic regulation

    Autonomic Nervous System Index (ANSI)

    Time frame: 6 months

  14. Change in nutrition quality

    American Heart Association (AHA) Diet Score

    Time frame: 6 months

  15. 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)

    Time frame: 6 months

  16. 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).

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2023 (actual). Primary completion is estimated for Dec 2024, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2023
First posted
Oct 23, 2023
StartActual
Jan 11, 2023
Primary completionEst.
Dec 1, 2024
CompletionEst.
Dec 31, 2024
Last update
Mar 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06094036
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Jan 11, 2023
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 12, 2024

Study contacts

Luca Giovanelli, MD
Contact
luca.giovanelli@unimi.it
+3902619112808
Daniela Lucini, MD, PhD
principal investigator · University of Milan; Istituto Auxologico Italiano, IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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