D-chiroinositol Administration in Hypogonadal Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2021-03-01

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.

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Detailed Description

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Conditions

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Male Hypogonadism Sexual Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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D-chiroinositol treatment

Group Type EXPERIMENTAL

D-chiroinositol

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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D-chiroinositol

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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No