Hypothalamic-pituitary Dysfunction in Diabetes

Hypogonadism Clinical Trial

— DIAPO  

Official title:

Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752591
• Other study ID #: 05C823
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Central Hypothyroidism
• Diabete Mellitus
• Diabetes Mellitus
• Hypergonadotropic Hypogonadism
• Hypogonadism
• Hypogonadotropic Hypogonadism
• Hypothyroidism

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