Hypothalamic-pituitary Dysfunction in Diabetes

Completed

• Conditions: Hypergonadotropic Hypogonadism; Diabete Mellitus; Hypogonadotropic Hypogonadism; Hypogonadism; Central Hypothyroidism
• Interventions: Diagnostic Test: Diagnostic testing

• Registration Number: NCT05752591
• Lead Sponsor: Istituto Auxologico Italiano

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-25
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Primary Completion: 2024-03-14
• Study Completion: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled patients with DM	Diagnostic testing	-

Primary Outcome Measures

Name	Time	Method
Prevalence of Hypogonadism	baseline	LH, FSH, Testosterone, Estradiol
Genetic predisposition	baseline	NGS analysis based on the analysis of a customized gene-panel with all known Congenital Hypogonadotropic Hypogonadism genes

Trial Locations

Locations (2)

Istituto Auxologico Italiano; 🇮🇹 Milan, Italy

ASST Fatebenefratelli Sacco; 🇮🇹 Milan, Italy