NCT04708249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

January 8, 2021

Last Update Submit

March 1, 2021

Conditions

Male HypogonadismSexual Dysfunction

Keywords

Male HypogonadismTestosteroneAromataseD-chiroinositolSexual dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change from Baseline Weight at 1 month

    At baseline and after 30 days of treatment

  • Change from Baseline Waist circumference at 1 month

    At baseline and after 30 days of treatment

  • Change from Baseline BMI at 1 month

    At baseline and after 30 days of treatment

  • Change from Baseline Insulin at 1 month

    At baseline and after 30 days of treatment

  • Change from Baseline Glycaemia at 1 month

    At baseline and after 30 days of treatment

  • +7 more secondary outcomes

Study Arms (1)

D-chiroinositol treatment

EXPERIMENTAL
Dietary Supplement: D-chiroinositol

Interventions

D-chiroinositolDIETARY_SUPPLEMENT

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

D-chiroinositol treatment

Eligibility Criteria

Age65 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men, with a diagnosis of Late-Onset Male Hypogonadism
  • Insulin resistance (HOMA Index \> 2,5)
  • BMI between 25 and 30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Alma Res

Rome, 00198, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34763665DERIVED

MeSH Terms

Conditions

EunuchismSexual Dysfunction, Physiological

Interventions

kasugamycin

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System DiseasesGenital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 13, 2021

Study Start

January 18, 2021

Primary Completion

February 24, 2021

Study Completion

March 1, 2021

Last Updated

March 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)