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NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY

S

San Donato Group (GSD)

Status

Not yet enrolling

Conditions

Bone Health
Obesity; Endocrine
Pituitary Dysfunction

Treatments

Diagnostic Test: Dexa or Biompedance analysis with clinical and biochemical evaluations

Study type

Observational

Funder types

Other

Identifiers

NCT06540820
PNRR-MCNT1-2023-12377758

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

150 participants in 2 patient groups

patients with pituitary disorders
Treatment:
Diagnostic Test: Dexa or Biompedance analysis with clinical and biochemical evaluations
patients without pituitary disorders
Treatment:
Diagnostic Test: Dexa or Biompedance analysis with clinical and biochemical evaluations

Trial contacts and locations

0

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Central trial contact

Luigi Di Filippo, medical doctor; Andrea Giustina, professor

Data sourced from clinicaltrials.gov

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