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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change in hypothalamic-pituitary-gonadal axis function | particularly testosterone levels (nmol/l) | 6 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Giovanelli, MD | Contact | +3902619112808 | luca.giovanelli@unimi.it |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Lucini, MD, PhD | University of Milan; Istituto Auxologico Italiano, IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano IRCCS | Recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| D024821 | Metabolic Syndrome |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
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|
| 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 |
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |