Bone Health, Obesity; Endocrine, Pituitary Dysfunction
Conditions
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.
Interventions
DIAGNOSTIC_TESTDexa 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.
Sponsors
Federico II University
University of Catanzaro
Istituto Auxologico Italiano
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactAndrea Giustina, professor
Backup ContactLuigi Di Filippo, medical doctor
Outcome results
None listed