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Clinical Trial NCT06094036 (ExLOH) for Hypogonadism, Male, Metabolic Syndrome, Autonomic Imbalance, Life Style, Healthy, Physical Inactivity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism (ExLOH)
Clinical Trial NCT06094036 (ExLOH) is an interventional study for Hypogonadism, Male, Metabolic Syndrome, Autonomic Imbalance, Life Style, Healthy, Physical Inactivity that is recruiting. It started on January 11, 2023 with plans to enroll 72 participants. Led by Istituto Auxologico Italiano, it is expected to complete by December 31, 2024. The latest data from ClinicalTrials.gov was last updated on March 12, 2024.
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.
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
Conditions
Hypogonadism, MaleMetabolic SyndromeAutonomic ImbalanceLife STYLE, HealthyPhysical InactivityOther Study IDs
- ExLOH
- 45C202
NCT ID Number
Start Date (Actual)
2023-01-11
Last Update Posted
2024-03-12
Completion Date (Estimated)
2024-12-31
Enrollment (Estimated)
72
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Single Group
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Otherweekly 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. | 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. |
Otherweekly 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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
change in hypothalamic-pituitary-gonadal axis function | particularly testosterone levels (nmol/l) | 6 months |
| 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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
- 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.
- 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.
Istituto Auxologico ItalianoStudy Central Contact
Contact: Luca Giovanelli, MD, +3902619112808, [email protected]
1 Study Locations in 1 Countries
Istituto Auxologico Italiano IRCCS, Milan, Italy
Luca Giovanelli, Contact, +3902619112808, [email protected]
Daniela Lucini, Principal Investigator
Recruiting