Back to resultsPhysical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism (ExLOH)
Primary Purpose
Hypogonadism, Male, Metabolic Syndrome, Autonomic Imbalance
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Structured and personalized program of physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism, Male
Eligibility Criteria
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.
Sites / Locations
- Istituto Auxologico Italiano IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
weekly physical activity volume performed above 600 MET·minutes/week
weekly physical activity volume performed below 600 MET·minutes/week
Arm Description
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
Outcomes
Primary Outcome Measures
change in hypothalamic-pituitary-gonadal axis function
particularly testosterone levels (nmol/l)
Secondary Outcome Measures
Change in body composition
percentage of fat mass and free fat mass
Change in serum skeletal isoenzyme of alkaline phosphatase
Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l)
Change in C-terminal telopeptide of type I collagen
Change in C-terminal telopeptide of type I collagen concentration (ng/l)
Change in erythrocyte sedimentation rate
Change in erythrocyte sedimentation rate (mm/h)
Change in C-reactive protein
Change in C-reactive protein concentration (mg/l)
Change in total cholesterol
Change in total cholesterol concentration (mg/dl)
Change in HDL cholesterol
Change in HDL cholesterol concentration (mg/dl)
Change in triglycerides
Change in triglycerides concentration (mg/dl)
Change in glucose profile
glycemia (mg/dl)
Change in kidney function
creatinine (mg/dl)
Change in aspartate aminotransferase
Change in aspartate aminotransferase concentration (U/L)
Change in alanine aminotransferase
Change in alanine aminotransferase concentration (U/L)
Change in cardiac autonomic regulation
Autonomic Nervous System Index (ANSI)
Change in nutrition quality
American Heart Association (AHA) Diet Score
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)
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).
Full Information
NCT ID
NCT06094036
First Posted
October 6, 2023
Last Updated
October 16, 2023
Sponsor
Istituto Auxologico Italiano
1. Study Identification
Unique Protocol Identification Number
NCT06094036
Brief Title
Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Male, Metabolic Syndrome, Autonomic Imbalance, Life Style, Healthy, Physical Inactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
weekly physical activity volume performed above 600 MET·minutes/week
Arm Type
Other
Arm Description
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
Arm Title
weekly physical activity volume performed below 600 MET·minutes/week
Arm Type
Other
Arm Description
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
Intervention Type
Behavioral
Intervention Name(s)
Structured and personalized program of physical exercise
Intervention Description
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 Measure Information:
Title
change in hypothalamic-pituitary-gonadal axis function
Description
particularly testosterone levels (nmol/l)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in body composition
Description
percentage of fat mass and free fat mass
Time Frame
6 months
Title
Change in serum skeletal isoenzyme of alkaline phosphatase
Description
Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l)
Time Frame
6 months
Title
Change in C-terminal telopeptide of type I collagen
Description
Change in C-terminal telopeptide of type I collagen concentration (ng/l)
Time Frame
6 months
Title
Change in erythrocyte sedimentation rate
Description
Change in erythrocyte sedimentation rate (mm/h)
Time Frame
6 months
Title
Change in C-reactive protein
Description
Change in C-reactive protein concentration (mg/l)
Time Frame
6 months
Title
Change in total cholesterol
Description
Change in total cholesterol concentration (mg/dl)
Time Frame
6 months
Title
Change in HDL cholesterol
Description
Change in HDL cholesterol concentration (mg/dl)
Time Frame
6 months
Title
Change in triglycerides
Description
Change in triglycerides concentration (mg/dl)
Time Frame
6 months
Title
Change in glucose profile
Description
glycemia (mg/dl)
Time Frame
6 months
Title
Change in kidney function
Description
creatinine (mg/dl)
Time Frame
6 months
Title
Change in aspartate aminotransferase
Description
Change in aspartate aminotransferase concentration (U/L)
Time Frame
6 months
Title
Change in alanine aminotransferase
Description
Change in alanine aminotransferase concentration (U/L)
Time Frame
6 months
Title
Change in cardiac autonomic regulation
Description
Autonomic Nervous System Index (ANSI)
Time Frame
6 months
Title
Change in nutrition quality
Description
American Heart Association (AHA) Diet Score
Time Frame
6 months
Title
Change in perception of stress, fatigue, and somatic symptoms
Description
short version of 4SQ questionnaire considering 4 specific symptoms (total score ranging from 0 to 40)
Time Frame
6 months
Title
Change in weekly physical activity volume
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Giovanelli, MD
Phone
+3902619112808
Email
luca.giovanelli@unimi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Lucini, MD, PhD
Organizational Affiliation
University of Milan; Istituto Auxologico Italiano, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Auxologico Italiano IRCCS
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Giovanelli
Phone
+3902619112808
Email
luca.giovanelli@unimi.it
First Name & Middle Initial & Last Name & Degree
Daniela Lucini
12. IPD Sharing Statement
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Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism
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