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L'essai clinique NCT06094036 (ExLOH) pour Hypogonadisme masculin, Syndrome métabolique, Déséquilibre autonome, Mode de vie sain, Inactivité physique est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Physical Exercise as a Sustainability Tool in Men With Dysmetabolic Hypogonadism (ExLOH)
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L'étude clinique NCT06094036 (ExLOH) est un essai interventionnel pour Hypogonadisme masculin, Syndrome métabolique, Déséquilibre autonome, Mode de vie sain, Inactivité physique. Son statut actuel est : en recrutement. L'étude a débuté le 11 janvier 2023 et vise à recruter 72 participants. Dirigé par Istituto Auxologico Italiano, l'essai devrait être terminé d'ici le 31 décembre 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 mars 2024.
Résumé succinct
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.
Titre officiel
Physical Exercise as a Sustainability Tool in Men Affected With Metabolic Syndrome-related Late-onset Central Hypogonadism: Role of Endocrine-metabolic and Neurovegetative Outcomes
Conditions
Hypogonadisme masculinSyndrome métaboliqueDéséquilibre autonomeMode de vie sainInactivité physiqueAutres identifiants de l'essai
- ExLOH
- 45C202
Numéro NCT
Date de début (réel)
2023-01-11
Dernière mise à jour publiée
2024-03-12
Date de fin (estimée)
2024-12-31
Inscription (estimée)
72
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Groupe unique
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Autreweekly physical activity volume performed above 600 MET·minutes/week Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals. | 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. |
Autreweekly physical activity volume performed below 600 MET·minutes/week Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals. | 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
change in hypothalamic-pituitary-gonadal axis function | particularly testosterone levels (nmol/l) | 6 months |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in body composition | percentage of fat mass and free fat mass | 6 months |
Change in serum skeletal isoenzyme of alkaline phosphatase | Change in serum skeletal isoenzyme of alkaline phosphatase concentration (ug/l) | 6 months |
Change in C-terminal telopeptide of type I collagen | Change in C-terminal telopeptide of type I collagen concentration (ng/l) | 6 months |
Change in erythrocyte sedimentation rate | Change in erythrocyte sedimentation rate (mm/h) | 6 months |
Change in C-reactive protein | Change in C-reactive protein concentration (mg/l) | 6 months |
Change in total cholesterol | Change in total cholesterol concentration (mg/dl) | 6 months |
Change in HDL cholesterol | Change in HDL cholesterol concentration (mg/dl) | 6 months |
Change in triglycerides | Change in triglycerides concentration (mg/dl) | 6 months |
Change in glucose profile | glycemia (mg/dl) | 6 months |
Change in kidney function | creatinine (mg/dl) | 6 months |
Change in aspartate aminotransferase | Change in aspartate aminotransferase concentration (U/L) | 6 months |
Change in alanine aminotransferase | Change in alanine aminotransferase concentration (U/L) | 6 months |
Change in cardiac autonomic regulation | Autonomic Nervous System Index (ANSI) | 6 months |
Change in nutrition quality | American Heart Association (AHA) Diet Score | 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) | 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). | 6 months |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Homme
- 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.
- 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.
Istituto Auxologico ItalianoContact central de l'essai
Contact: Luca Giovanelli, MD, +3902619112808, [email protected]
1 Centres de l'essai dans 1 pays
Istituto Auxologico Italiano IRCCS, Milan, Italy
Luca Giovanelli, Contact, +3902619112808, [email protected]
Daniela Lucini, Investigateur principal
En recrutement