D-chiroinositol Administration in Hypogonadal Males

Study Overview
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Brief Summary
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D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.

Official Title
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D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males

Conditions
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Male Hypogonadism, Sexual Dysfunction

Intervention / Treatment
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* Dietary Supplement: D-chiroinositol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men, with a diagnosis of Late-Onset Male Hypogonadism Insulin resistance (HOMA Index > 2,5) BMI between 25 and 30 Exclusion Criteria: Alcohol intake and/or drug abuse Recent hormonal treatment Smoking Obesity Systemic or endocrine diseases Male accessory gland infection Clinical history of cryptorchidism or varicocele and micro-orchidism

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-chiroinositol treatment<br> | Dietary Supplement: D-chiroinositol<br>* Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Serum Testosterone at 1 month | Level of testosterone detected in the blood in ng/dL | At baseline and after 30 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Weight at 1 month | Body weight of patients reported in kg | At baseline and after 30 days of treatment | 
| Change from Baseline Waist circumference at 1 month | Waist circumference of patients reported in cm | At baseline and after 30 days of treatment | 
| Change from Baseline BMI at 1 month | Body Mass Index of patients calculated as kg/m2, where kg is the weight measured for eah patient while m2 is his height squared | At baseline and after 30 days of treatment | 
| Change from Baseline Insulin at 1 month | Level of fasting insulin detected in the blood and reported in microU/L | At baseline and after 30 days of treatment | 
| Change from Baseline Glycaemia at 1 month | Level of fasting glycaemia detected in the blood and reported in mg/dL | At baseline and after 30 days of treatment | 
| Change from Baseline HOMA index at 1 month | HOMA index known as Homeostatic Model Assessment for Insulin Resistance is: (fasting glycaemia x fasting insulin)/405 | At baseline and after 30 days of treatment | 
| Change from Baseline Androstenedione at 1 month | Level of androstenedione detected in the blood and reported in ng/mL | At baseline and after 30 days of treatment | 
| Change from Baseline Luteinizing Hormone at 1 month | Level of luteinizing hormone detected in the blood and reported in mUI/ml | At baseline and after 30 days of treatment | 
| Change from Baseline Oestradiol at 1 month | Level of oestradiol detected in the blood and reported in pg/mL | At baseline and after 30 days of treatment | 
| Change from Baseline Oestrone at 1 month | Level of oestrone detected in the blood and reported in pg/mL | At baseline and after 30 days of treatment | 
| Change from Baseline Testosterone/Oestradiol ratio at 1 month | Ratio between the levels of oestradiol and testosterone detected in the blood | At baseline and after 30 days of treatment | 
| Change from Baseline Strength Test at 1 month | Measurement of strength performed with the dominant hand using a hand-held dynamometer (Good Strength, IGS01, Metitur Oy, Jyväskylä, Finland) with the participant in the seated position with elbow flexed at 110°. The participant will be instructed to squeeze the handle as hard as possible for 3-5 seconds and the stregth will be recorded in kg | At baseline and after 30 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Hypogonadism, Testosterone, Aromatase, D-chiroinositol, Sexual dysfunction