Trials / Completed
CompletedNCT05752591
Hypothalamic-pituitary Dysfunction in Diabetes
Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- Istituto Auxologico Italiano · Academic / Other
- Sex
- Male
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Diabete Mellitus
- Hypogonadism
- Hypogonadotropic Hypogonadism
- Hypergonadotropic Hypogonadism
- Central Hypothyroidism
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-05-25
- Primary completion
- 2024-03-14
- Completion
- 2024-03-14
- First posted
- 2023-03-02
- Last updated
- 2024-03-15
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT05752591. Inclusion in this directory is not an endorsement.