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| Name | Class |
|---|---|
| Federico II University | OTHER |
| University of Catanzaro | OTHER |
| Istituto Auxologico Italiano | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with pituitary disorders |
| ||
| patients without pituitary disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexa or Biompedance analysis with clinical and biochemical evaluations | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
b) Adipokines and obesity-associated cytokines serum content. c) Osteokines serum content. | 2 weeks |
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Inclusion criteria for subjects with pituitary disease:
Inclusion criteria for subjects without pituitary disease
Exclusion Criteria:
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Obese patients with or without pituitary/gonadal disorders will be enrolled. 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.
A total of n=150 obese individuals will be recruited as it follows:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Giustina, professor | Contact | 0226435062 | giustina.andrea@hsr.it | |
| Luigi Di Filippo, medical doctor | Contact | 0226435062 | difilippo.luigi@hsr.it |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |