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NCT05752591
Hypothalamic-pituitary Dysfunction in Diabetes
Conditions: Diabete Mellitus, Hypogonadism, Hypogonadotropic Hypogonadism, Hypergonadotropic Hypogonadism, Central Hypothyroidism
Sex: Male
Ages: 18 Years – 80 Years
Enrollment: 150
Sponsor: Istituto Auxologico Italiano
Location: Italy
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.
Eligibility Criteria
Inclusion Criteria:age between 18 and 80 years oldmalesproved diagnosis of T2DMExclusion 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/dLmalnutrition with BMI <17 Kg/m2use of glucocorticoids at the enrollmentpoor understanding of spoken and written Italianpatients affected with known primary diseases of the testes at the enrollment
Source: ClinicalTrials.gov (NCT05752591). StuddyBuddy aggregates publicly available trial information.