D-chiroinositol Administration in Hypogonadal Males

Overview

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.

Full Title of Study: “D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 24, 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: D-chiroinositol treatment

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from Baseline Weight at 1 month
    • Time Frame: At baseline and after 30 days of treatment
    • Body weight of patients reported in kg
  • Change from Baseline Waist circumference at 1 month
    • Time Frame: At baseline and after 30 days of treatment
    • Waist circumference of patients reported in cm
  • Change from Baseline BMI at 1 month
    • Time Frame: 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
    • Time Frame: At baseline and after 30 days of treatment
    • Level of fasting insulin detected in the blood and reported in microU/L
  • Change from Baseline Glycaemia at 1 month
    • Time Frame: At baseline and after 30 days of treatment
    • Level of fasting glycaemia detected in the blood and reported in mg/dL
  • Change from Baseline HOMA index at 1 month
    • Time Frame: 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 Androstenedione at 1 month
    • Time Frame: At baseline and after 30 days of treatment
    • Level of androstenedione detected in the blood and reported in ng/mL
  • Change from Baseline Luteinizing Hormone at 1 month
    • Time Frame: At baseline and after 30 days of treatment
    • Level of luteinizing hormone detected in the blood and reported in mUI/ml
  • Change from Baseline Oestradiol at 1 month
    • Time Frame: 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
    • Time Frame: At baseline and after 30 days of treatment
    • Level of oestrone detected in the blood and reported in pg/mL
  • Change from Baseline Testosterone/Oestradiol ratio at 1 month
    • Time Frame: At baseline and after 30 days of treatment
    • Ratio between the levels of oestradiol and testosterone detected in the blood
  • Change from Baseline Strength Test at 1 month
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 65 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lo.Li.Pharma s.r.l
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Maurizio Nordio, MD, 3331285693, maurizionordio1@gmail.com

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