NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-09-30

Brief Summary

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

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Detailed Description

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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

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Obesity; Endocrine Pituitary Dysfunction Bone Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patients with pituitary disorders

Dexa or Biompedance analysis with clinical and biochemical evaluations

Intervention Type 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.

patients without pituitary disorders

Dexa or Biompedance analysis with clinical and biochemical evaluations

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

* Male and female subject \> 18-year-old
* BMI ≥ 30 Kg/m2
* Able to sign an informed consent