Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Istituto Auxologico Italiano72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

change in hypothalamic-pituitary-gonadal axis function

particularly testosterone levels (nmol/l)

Time frame: 6 months

Secondary Outcomes

Change in body composition

percentage of fat mass and free fat mass

Time frame: 6 months

Change in serum skeletal isoenzyme of alkaline phosphatase

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

Time frame: 6 months

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

Change in erythrocyte sedimentation rate

Change in erythrocyte sedimentation rate (mm/h)

Time frame: 6 months

Change in C-reactive protein

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

Time frame: 6 months

Change in total cholesterol

Change in total cholesterol concentration (mg/dl)

Time frame: 6 months

Change in HDL cholesterol

Change in HDL cholesterol concentration (mg/dl)

Time frame: 6 months

Change in triglycerides

Change in triglycerides concentration (mg/dl)

Time frame: 6 months

Change in glucose profile

glycemia (mg/dl)

Time frame: 6 months

Change in kidney function

creatinine (mg/dl)

Time frame: 6 months

Change in aspartate aminotransferase

Change in aspartate aminotransferase concentration (U/L)

Time frame: 6 months

Change in alanine aminotransferase

Change in alanine aminotransferase concentration (U/L)

Time frame: 6 months

Change in cardiac autonomic regulation

Autonomic Nervous System Index (ANSI)

Time frame: 6 months

Change in nutrition quality

American Heart Association (AHA) Diet Score

Time frame: 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)

Time frame: 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).

Time frame: 6 months

Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts