Autonomic Imbalance, Hypogonadism, Male, Life Style, Healthy, Metabolic Syndrome, Physical Inactivity
Conditions
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.
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.
Sponsors
Istituto Auxologico Italiano
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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 informed consent, in accordance with good clinical practice rules and applicable national laws.
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in hypothalamic-pituitary-gonadal axis function | 6 months | particularly testosterone levels (nmol/l) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total cholesterol | 6 months | Change in total cholesterol concentration (mg/dl) |
| Change in HDL cholesterol | 6 months | Change in HDL cholesterol concentration (mg/dl) |
| Change in triglycerides | 6 months | Change in triglycerides concentration (mg/dl) |
| Change in glucose profile | 6 months | glycemia (mg/dl) |
| Change in kidney function | 6 months | creatinine (mg/dl) |
| Change in aspartate aminotransferase | 6 months | Change in aspartate aminotransferase concentration (U/L) |
| Change in alanine aminotransferase | 6 months | Change in alanine aminotransferase concentration (U/L) |
| Change in C-reactive protein | 6 months | Change in C-reactive protein concentration (mg/l) |
| Change in body composition | 6 months | percentage of fat mass and free fat mass |
| Change in serum skeletal isoenzyme of alkaline phosphatase | 6 months | Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l) |
| Change in erythrocyte sedimentation rate | 6 months | Change in erythrocyte sedimentation rate (mm/h) |
| Change in cardiac autonomic regulation | 6 months | Autonomic Nervous System Index (ANSI) |
| Change in nutrition quality | 6 months | American Heart Association (AHA) Diet Score |
| Change in perception of stress, fatigue, and somatic symptoms | 6 months | short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40) |
| Change in weekly physical activity volume | 6 months | 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). |
| Change in C-terminal telopeptide of type I collagen | 6 months | Change in C-terminal telopeptide of type I collagen concentration (ng/l) |
Countries
Italy
Contacts
Primary ContactLuca Giovanelli, MD
Outcome results
None listed