Central Hypothyroidism, Diabete Mellitus, Hypergonadotropic Hypogonadism, Hypogonadism, Hypogonadotropic Hypogonadism
Conditions
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.
Interventions
DIAGNOSTIC_TESTDiagnostic 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
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed