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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-chiroinositol treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-chiroinositol | Dietary Supplement | Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Alma Res | Rome | 00198 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34763665 | Derived | Nordio M, Kumanov P, Chiefari A, Puliani G. D-Chiro-Inositol improves testosterone levels in older hypogonadal men with low-normal testosterone: a pilot study. Basic Clin Androl. 2021 Nov 12;31(1):28. doi: 10.1186/s12610-021-00146-4. |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C100305 | kasugamycin |
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| 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 |
| D000091642 |
| Urogenital Diseases |