NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY

NCT06540820 | Not Yet Recruiting

• 1 other identifier: PNRR-MCNT1-2023-12377758
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity; Endocrine; Pituitary Dysfunction; Bone Health

Outcome Measures

Primary Outcomes (1)

• 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: 1. Biochemical exams to determine the presence of primary or secondary hypogonadism or other alterations of the neuroendocrine axis. 2. 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.

  2 weeks

Study Arms (2)

patients with pituitary disorders

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

patients without pituitary disorders

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

Interventions

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.

patients with pituitary disorders; patients without pituitary disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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: 1. n=30 obese patients with acromegaly 2. n=30 obese patients with hyperprolactinemia 3. n=30 obese patients with hypopituitarism, including secondary male hypogonadism 4. n=30 obese patients with Cushing syndrome 5. n=30 obese patients without neuroendocrine diseases as control group

You may qualify if:

• 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

You may not qualify if:

• Male and female subject \<18-year-old
• pregnant or breastfeeding women
• Subject unable to sign informed consent
• BMI \< 30 Kg/m2

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Federico II University: collaborator
• University of Catanzaro: collaborator
• Istituto Auxologico Italiano: collaborator

MeSH Terms

Conditions

Obesity

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Andrea Giustina, professor

CONTACT

0226435062; giustina.andrea@hsr.it

Luigi Di Filippo, medical doctor

CONTACT

0226435062; difilippo.luigi@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share