D-chiroinositol Administration in Hypogonadal Males

Not Applicable

Completed

• Conditions: Sexual Dysfunction; Male Hypogonadism
• Interventions: Dietary Supplement: D-chiroinositol

• Registration Number: NCT04708249
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Study Start: 2021-01-18
• Primary Completion: 2021-02-24
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D-chiroinositol treatment	D-chiroinositol	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Serum Testosterone at 1 month	At baseline and after 30 days of treatment	Level of testosterone detected in the blood in ng/dL

Secondary Outcome Measures

Name	Time	Method
Change from Baseline BMI at 1 month	At baseline and after 30 days of treatment	Body Mass Index of patients calculated as kg/m2, where kg is the weight measured for eah patient while m2 is his height squared
Change from Baseline Insulin at 1 month	At baseline and after 30 days of treatment	Level of fasting insulin detected in the blood and reported in microU/L
Change from Baseline HOMA index at 1 month	At baseline and after 30 days of treatment	HOMA index known as Homeostatic Model Assessment for Insulin Resistance is: (fasting glycaemia x fasting insulin)/405
Change from Baseline Luteinizing Hormone at 1 month	At baseline and after 30 days of treatment	Level of luteinizing hormone detected in the blood and reported in mUI/ml
Change from Baseline Waist circumference at 1 month	At baseline and after 30 days of treatment	Waist circumference of patients reported in cm
Change from Baseline Weight at 1 month	At baseline and after 30 days of treatment	Body weight of patients reported in kg
Change from Baseline Androstenedione at 1 month	At baseline and after 30 days of treatment	Level of androstenedione detected in the blood and reported in ng/mL
Change from Baseline Testosterone/Oestradiol ratio at 1 month	At baseline and after 30 days of treatment	Ratio between the levels of oestradiol and testosterone detected in the blood
Change from Baseline Glycaemia at 1 month	At baseline and after 30 days of treatment	Level of fasting glycaemia detected in the blood and reported in mg/dL
Change from Baseline Oestradiol at 1 month	At baseline and after 30 days of treatment	Level of oestradiol detected in the blood and reported in pg/mL
Change from Baseline Oestrone at 1 month	At baseline and after 30 days of treatment	Level of oestrone detected in the blood and reported in pg/mL
Change from Baseline Strength Test at 1 month	At baseline and after 30 days of treatment	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

Trial Locations

Locations (1)

Clinica Alma Res; 🇮🇹 Rome, Italy