NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexa or Biompedance analysis with clinical and biochemical evaluations.
- Who it may be relevant to
- Registry conditions: Obesity; Endocrine, Pituitary Dysfunction, Bone Health. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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 acti
Primary outcome measures
- 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. [Time frame: 2 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06540820 · PNRR-MCNT1-2023-12377758