Hypothalamic-pituitary Dysfunction in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-25

Study Completion Date

2024-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabete Mellitus Hypogonadism Hypogonadotropic Hypogonadism Hypergonadotropic Hypogonadism Central Hypothyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Enrolled patients with DM

Diagnostic testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No