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NCT Number: NCT05752591

Hypothalamic-pituitary Dysfunction in Diabetes

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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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

ASST Fatebenefratelli Sacco, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic testing

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

Primary outcomes

  1. Prevalence of Hypogonadism

    Time frame: baseline

    LH, FSH, Testosterone, Estradiol

  2. Genetic predisposition

    Time frame: baseline

    NGS analysis based on the analysis of a customized gene-panel with all known Congenital Hypogonadotropic Hypogonadism genes

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus

Acronym: DIAPO

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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