Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06094036
Other study ID # 45C202
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A