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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04708249
Other study ID # DCI_HYPOGONADAL_MALES
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2021
Est. completion date March 1, 2021

Study information

Verified date January 2021
Source Lo.Li.Pharma s.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 1, 2021
Est. primary completion date February 24, 2021
Accepts healthy volunteers No
Gender Male
Age group 65 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
D-chiroinositol
Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.

Locations

Country Name City State
Italy Clinica Alma Res Rome

Sponsors (1)

Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from Baseline Weight at 1 month Body weight of patients reported in kg At baseline and after 30 days of treatment
Secondary Change from Baseline Waist circumference at 1 month Waist circumference of patients reported in cm At baseline and after 30 days of treatment
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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