NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Health; Pituitary Dysfunction; Obesity; Endocrine
• Intervention / Treatment: Diagnostic test: Dexa or Biompedance analysis with clinical and biochemical evaluations

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Andrea Giustina, professor; Phone Number: 0226435062; Email: giustina.andrea@hsr.it
• Study Contact Backup: Name: Luigi Di Filippo, medical doctor; Phone Number: 0226435062; Email: difilippo.luigi@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Obese patients with or without pituitary/gonadal disorders will be enrolled. 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.

A total of n=150 obese individuals will be recruited as it follows:

1. n=30 obese patients with acromegaly
2. n=30 obese patients with hyperprolactinemia
3. n=30 obese patients with hypopituitarism, including secondary male hypogonadism
4. n=30 obese patients with Cushing syndrome
5. n=30 obese patients without neuroendocrine diseases as control group

Description

Inclusion criteria for subjects with pituitary disease:

• Male and female subject > 18-year-old (also fertile patients can be included)
• Patients with prolactinoma or Cushing disease, Acromegaly or hypogonadism/hypopituitarism
• BMI ≥30 Kg/m2
• Able to sign an informed consent

Inclusion criteria for subjects without pituitary disease

• Male and female subject > 18-year-old
• BMI ≥ 30 Kg/m2
• Able to sign an informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with pituitary disorders	Diagnostic test: Dexa or Biompedance analysis with clinical and biochemical evaluations; All patients will undergo body composition study with DXA or Bioimpedance analysis which are the gold standard to determine % of fat mass and fat free mass, basal biochemical examinations and oral glucose tolerance test (OGTT), and clinical evaluation with waist circumference measurement. Moreover, all patients will undergo REMS ultrasound, TBS and BSI evaluation at DXA scan and hand grip test. In addition, all patients will undergo to clinical evaluation with specific nutritional, physical activity and sleep quality questionnaire assessments and an additional volume of blood.
patients without pituitary disorders	Diagnostic test: Dexa or Biompedance analysis with clinical and biochemical evaluations; All patients will undergo body composition study with DXA or Bioimpedance analysis which are the gold standard to determine % of fat mass and fat free mass, basal biochemical examinations and oral glucose tolerance test (OGTT), and clinical evaluation with waist circumference measurement. Moreover, all patients will undergo REMS ultrasound, TBS and BSI evaluation at DXA scan and hand grip test. In addition, all patients will undergo to clinical evaluation with specific nutritional, physical activity and sleep quality questionnaire assessments and an additional volume of blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The following assessments will be performed: Biochemical exams to determine the presence of primary or secondary hypogonadism or other alterations of the neuroendocrine axis.; 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.	2 weeks

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Federico II University; Istituto Auxologico Italiano; University of Catanzaro

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PNRR-MCNT1-2023-12377758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No