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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05752591
Other study ID # 05C823
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2018
Est. completion date March 14, 2024

Study information

Verified date March 2024
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 14, 2024
Est. primary completion date March 14, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - age between 18 and 80 years old - males - proved diagnosis of T2DM Exclusion Criteria: - patients affected with known hypothalamic-pituitary diseases at the enrollment. - patients affected with severe systemic diseases, fever, chronic inflammatory disorders with PCR > 10 mg/dL - malnutrition with BMI <17 Kg/m2 - use of glucocorticoids at the enrollment - poor understanding of spoken and written Italian - patients affected with known primary diseases of the testes at the enrollment

Study Design


Intervention

Diagnostic Test:
Diagnostic testing
Blood diagnostic testing for hypothalamic-pituitary-gonadal axis and hypothalamic-pituitary-thyroid axis. In case of gonadal or thyroid dysfunction, genetic testing for known implicated genes

Locations

Country Name City State
Italy ASST Fatebenefratelli Sacco Milan
Italy Istituto Auxologico Italiano Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Hypogonadism LH, FSH, Testosterone, Estradiol baseline
Primary Genetic predisposition NGS analysis based on the analysis of a customized gene-panel with all known Congenital Hypogonadotropic Hypogonadism genes baseline
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