NEUROENDOCRINE REGULATION OF BONE-FAT C… | Clinical Trial

Key information

Conditions

Obesity; Endocrine Body Weight Bone Health Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pituitary Dysfunction Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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
The following assessments will be performed:
- Biochemical exams to determine the presence of primary or secondary hypogonadism or other alterations of the neuroendocrine axis.
- Bone health: -Blood and urine samples -Hip, lumbar and ultradistal BMD by DXA; -Vertebral fractures assessment on lateral dorso-lumbar spine DXA scans by a quantitative morphometric approach. -Bone microarchitectural and microstructural characteristics, performing TBS. -Distal HRpQCT -Bone Strain index (BSi) parameters from hip and lumbar DXA scans, obtaining a qualitative index of bone strength based on finite element analysis.
b) Adipokines and obesity-associated cytokines serum content. c) Osteokines serum content.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Giustina, professor

CONTACT

[email protected]

0226435062

Luigi Di Filippo, medical doctor

CONTACT

[email protected]

0226435062

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

Federico II University
Istituto Auxologico Italiano
University of Catanzaro

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 6, 2024
Registry last updated: Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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