NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY

IRCCS San Raffaele150 enrolled

Overview

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

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

150

Conditions

Obesity; Endocrine Pituitary Dysfunction Bone Health

Interventions

Dexa or Biompedance analysis with clinical and biochemical evaluationsDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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: 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.

Time frame: 2 weeks

Central Contacts

Andrea Giustina, professor

CONTACT

0226435062 giustina.andrea@hsr.it

Luigi Di Filippo, medical doctor

CONTACT

0226435062 difilippo.luigi@hsr.it

Data from ClinicalTrials.gov

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