Hypothalamic-pituitary Dysfunction in Diabetes (DIAPO)

Istituto Auxologico Italiano

Status: Completed

Conditions: Hypergonadotropic Hypogonadism; Diabete Mellitus; Hypogonadotropic Hypogonadism; Central Hypothyroidism; Hypogonadism

Treatments: Diagnostic Test: Diagnostic testing

Study type: Observational

Funder types: Other

Identifiers

NCT05752591

05C823

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Enrolled patients with DM

Treatment:

Diagnostic Test: Diagnostic testing