Hypothalamic-pituitary Dysfunction in Diabetes

NCT05752591 | Completed

• 1 other identifier: 05C823
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabete Mellitus; Hypogonadism; Hypogonadotropic Hypogonadism; Hypergonadotropic Hypogonadism; Central Hypothyroidism

Outcome Measures

Primary Outcomes (2)

• Prevalence of Hypogonadism

  LH, FSH, Testosterone, Estradiol

  baseline

• Genetic predisposition

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

  baseline

Study Arms (1)

Enrolled patients with DM

Diagnostic Test: Diagnostic testing

Interventions

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

Enrolled patients with DM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age between 18 and 80 years old
• males
• proved diagnosis of T2DM

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (2)

Istituto Auxologico Italiano

Milan, 20145, Italy

Location

ASST Fatebenefratelli Sacco

Milan, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma Whoole Blood DNA

MeSH Terms

Conditions

Diabetes Mellitus; Hypogonadism; Hypothyroidism

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Gonadal Disorders; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: May 25, 2018
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

IT (2)