NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY

Not yet recruiting

• Conditions: Bone Health; Pituitary Dysfunction; Obesity; Endocrine
• Interventions: Diagnostic Test: Dexa or Biompedance analysis with clinical and biochemical evaluations

• Registration Number: NCT06540820
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

To study the effect of neuroendocrine dysfunctions on bone health in obesity

Detailed Description

It is a multicentric, observational, cross-sectional non-profit study with additional procedures. The study will include obese patients (BMI\>30) with and without hyper functioning pituitary adenomas (acromegaly, Cushing and prolactinoma) and hypopituitarism (GH deficiency, secondary hypogonadism) aimed at studying the effect of metabolic phenotypes of obesity and neuroendocrine dysfunctions on bone health.

Patients enrollment will take place in Ospedale San Raffaele, Azienda Ospedaliera Universitaria Federico II di Napoli and UOC Endocrinologia-AOU Renato Dulbecco, Università degli Studi di Catanzaro Magna Graecia.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06
• Study Start: 2024-09
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

• Male and female subject <18-year-old
• pregnant or breastfeeding women
• Subject unable to sign informed consent
• BMI < 30 Kg/m2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with pituitary disorders	Dexa or Biompedance analysis with clinical and biochemical evaluations	-
patients without pituitary disorders	Dexa or Biompedance analysis with clinical and biochemical evaluations	-

Primary Outcome Measures

Name	Time	Method
To study the neuroendocrine control of bone-fat crosstalk in obesity. Obese patients with and without neuroendocrine dysfunctions will be enrolled in the study to evaluate bone health, as well as the content of circulating adipokines/osteokines.	2 weeks	The following assessments will be performed: 1. Biochemical exams to determine the presence of primary or secondary hypogonadism or other alterations of the neuroendocrine axis.; 2. Bone health: -Blood and urine samples -Hip, lumbar and ultradistal BMD by DXA; -Vertebral fractures assessment on lateral dorso-lumbar spine DXA scans by a quantitative morphometric approach. -Bone microarchitectural and microstructural characteristics, performing TBS. -Distal HRpQCT -Bone Strain index (BSi) parameters from hip and lumbar DXA scans, obtaining a qualitative index of bone strength based on finite element analysis.; b) Adipokines and obesity-associated cytokines serum content. c) Osteokines serum content.