DIAPO: Hypothalamic-pituitary Dysfunction in Diabetes

• Sponsor: Istituto Auxologico Italiano (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05752591
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 67.2
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabete Mellitus; Hypogonadism; Hypogonadotropic Hypogonadism; Hypergonadotropic Hypogonadism; Central Hypothyroidism	Diagnostic Test: Diagnostic testing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study of the Hypothalamic-pituitary Dysfuntion in Patients With Diabetes Mellitus
• Actual Study Start Date: May 25, 2018
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Prevalence of Hypogonadism [baseline]

   LH, FSH, Testosterone, Estradiol

2. Genetic predisposition [baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Auxologico Italiano	Milan		Italy	20145

Sponsors and Collaborators

• Istituto Auxologico Italiano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marco Bonomi, MD, Professor, Istituto Auxologico Italiano
• ClinicalTrials.gov Identifier: NCT05752591
• Other Study ID Numbers: 05C823
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Hypogonadism; Hypothyroidism

Study Results

No Results Posted as of Mar 2, 2023