Hypogonadism, MaleExLOHNCT06094036
Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism
A study testing Structured and personalized program of physical exercise in people with Hypogonadism, Male and Metabolic Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Hypogonadism, Male, Metabolic Syndrome, Autonomic Imbalance
- What is being tested?
- Structured and personalized program of physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan
Luca Giovanelli, +3902619112808, luca.giovanelli@unimi.it
Daniela Lucini
About this study
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
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
- Being tested
- Structured and personalized program of physical exercise
- Medical subject headings
- Eunuchism, Metabolic Syndrome, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured and personalized program of physical exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Structured and personalized program of physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hypothalamic-pituitary-gonadal axis function
particularly testosterone levels (nmol/l)
Measured: 6 months
Secondary outcomes (16)
Change in body composition
percentage of fat mass and free fat mass
Measured: 6 months
Change in serum skeletal isoenzyme of alkaline phosphatase
Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l)
Measured: 6 months
Change in C-terminal telopeptide of type I collagen
Change in C-terminal telopeptide of type I collagen concentration (ng/l)
Measured: 6 months
Change in erythrocyte sedimentation rate
Change in erythrocyte sedimentation rate (mm/h)
Measured: 6 months
Change in C-reactive protein
Change in C-reactive protein concentration (mg/l)
Measured: 6 months
Change in total cholesterol
Change in total cholesterol concentration (mg/dl)
Measured: 6 months
Change in HDL cholesterol
Change in HDL cholesterol concentration (mg/dl)
Measured: 6 months
Change in triglycerides
Change in triglycerides concentration (mg/dl)
Measured: 6 months
Change in glucose profile
glycemia (mg/dl)
Measured: 6 months
Change in kidney function
creatinine (mg/dl)
Measured: 6 months
Change in aspartate aminotransferase
Change in aspartate aminotransferase concentration (U/L)
Measured: 6 months
Change in alanine aminotransferase
Change in alanine aminotransferase concentration (U/L)
Measured: 6 months
Change in cardiac autonomic regulation
Autonomic Nervous System Index (ANSI)
Measured: 6 months
Change in nutrition quality
American Heart Association (AHA) Diet Score
Measured: 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)
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start11 Jan 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Lucini, MD, PhD, Principal investigator, University of Milan; Istituto Auxologico Italiano, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094036
- Sponsor's protocol ID
- 45C202
- Acronym
- ExLOH
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06094036
- Acronym / sponsor ID
- ExLOH / 45C202
- Conditions
- Hypogonadism, Male, Metabolic Syndrome, Autonomic Imbalance, Life Style, Healthy, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weekly physical activity volume performed above 600 MET·minutes/week | Other | Behavioral: Structured and personalized program of physical exerciseExercise 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 | Other | Behavioral: Structured and personalized program of physical exerciseExercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured and personalized program of physical exerciseIn 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. | Behavioural | weekly physical activity volume performed above 600 MET·minutes/week, weekly physical activity volume performed below 600 MET·minutes/week |
Primary outcome
change in hypothalamic-pituitary-gonadal axis function
Time frame: 6 months
particularly testosterone levels (nmol/l)
16 secondary outcomes
Change in body composition
Time frame: 6 months
Change in serum skeletal isoenzyme of alkaline phosphatase
Time frame: 6 months
Change in C-terminal telopeptide of type I collagen
Time frame: 6 months
Change in erythrocyte sedimentation rate
Time frame: 6 months
Change in C-reactive protein
Time frame: 6 months
Change in total cholesterol
Time frame: 6 months
Change in HDL cholesterol
Time frame: 6 months
Change in triglycerides
Time frame: 6 months
Change in glucose profile
Time frame: 6 months
Change in kidney function
Time frame: 6 months
Change in aspartate aminotransferase
Time frame: 6 months
Change in alanine aminotransferase
Time frame: 6 months
Change in cardiac autonomic regulation
Time frame: 6 months
Change in nutrition quality
Time frame: 6 months
Change in perception of stress, fatigue, and somatic symptoms
Time frame: 6 months
Change in weekly physical activity volume
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Related trials for Hypogonadism, Male
RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingPhase 4
Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance
Prostate Cancer, Hypogonadism, Male
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Lucini, MD, PhD principal investigator
University of Milan; Istituto Auxologico Italiano, IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured and personalized program of physical exercise in people with Hypogonadism, Male and Metabolic Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Giovanelli, MD (+3902619112808, luca.giovanelli@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in hypothalamic-pituitary-gonadal axis function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.