Hypothalamic-pituitary Dysfunction in Diabetes (DIAPO)

March 13, 2024 updated by: Marco Bonomi, Istituto Auxologico Italiano

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20145
        • Istituto Auxologico Italiano
      • Milan, Italy
        • Asst Fatebenefratelli Sacco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Cross-sectional, observational study in T2DM patients (minimum 150). The inclusion will be through consecutive enrollment in diabetology clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enrolled patients with DM
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Hypogonadism
Time Frame: baseline
LH, FSH, Testosterone, Estradiol
baseline
Genetic predisposition
Time Frame: baseline
NGS analysis based on the analysis of a customized gene-panel with all known Congenital Hypogonadotropic Hypogonadism genes
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2018

Primary Completion (Actual)

March 14, 2024

Study Completion (Actual)

March 14, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05C823

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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