NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
To study the effect of neuroendocrine dysfunctions on bone health in obesity
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Male and female subject <18-year-old
pregnant or breastfeeding women
Subject unable to sign informed consent
BMI < 30 Kg/m2
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Dexa or Biompedance analysis with clinical and biochemical evaluations
Diagnostic testAll 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: patients with pituitary disorders1 intervention
Group B: patients without pituitary disorders1 intervention
Trial outcomes
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.
Time frame
2 weeksLocations
Sponsors and contacts
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IRCCS San Raffaele
Lead sponsor
Federico II University
Collaborator
University of Catanzaro
Collaborator
Istituto Auxologico Italiano
Collaborator
Source ClinicalTrials.gov
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