NCT06540820

NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity; Endocrine
• Pituitary Dysfunction
• Bone Health

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-08-06
• Last updated: 2024-08-06