Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism

Metabolic Syndrome Clinical Trial

— ExLOH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094036
• Other study ID #: 45C202
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Luca Giovanelli, MD
• Phone: +3902619112808
• Email: luca.giovanelli[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in hypothalamic-pituitary-gonadal axis function	particularly testosterone levels (nmol/l)	6 months
Secondary	Change in body composition	percentage of fat mass and free fat mass	6 months
Secondary	Change in serum skeletal isoenzyme of alkaline phosphatase	Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l)	6 months
Secondary	Change in C-terminal telopeptide of type I collagen	Change in C-terminal telopeptide of type I collagen concentration (ng/l)	6 months
Secondary	Change in erythrocyte sedimentation rate	Change in erythrocyte sedimentation rate (mm/h)	6 months
Secondary	Change in C-reactive protein	Change in C-reactive protein concentration (mg/l)	6 months
Secondary	Change in total cholesterol	Change in total cholesterol concentration (mg/dl)	6 months
Secondary	Change in HDL cholesterol	Change in HDL cholesterol concentration (mg/dl)	6 months
Secondary	Change in triglycerides	Change in triglycerides concentration (mg/dl)	6 months
Secondary	Change in glucose profile	glycemia (mg/dl)	6 months
Secondary	Change in kidney function	creatinine (mg/dl)	6 months
Secondary	Change in aspartate aminotransferase	Change in aspartate aminotransferase concentration (U/L)	6 months
Secondary	Change in alanine aminotransferase	Change in alanine aminotransferase concentration (U/L)	6 months
Secondary	Change in cardiac autonomic regulation	Autonomic Nervous System Index (ANSI)	6 months
Secondary	Change in nutrition quality	American Heart Association (AHA) Diet Score	6 months
Secondary	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
Secondary	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