Obesity; EndocrineNCT06540820
NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY
An observational study of Obesity; Endocrine and Pituitary Dysfunction, run by IRCCS San Raffaele.
Trial summary
To study the effect of neuroendocrine dysfunctions on bone health in obesity Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity; Endocrine, Pituitary Dysfunction, Bone Health
- What is being tested?
- Dexa or Biompedance analysis with clinical and biochemical evaluations
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Male and female subject <18-year-old
- pregnant or breastfeeding women
- Subject unable to sign informed consent
- BMI < 30 Kg/m2
Trial locations and contacts
No sites are listed yet.
About this study
To study the effect of neuroendocrine dysfunctions on bone health in obesity
Read the detailed description
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
- Obesity; Endocrine, Pituitary Dysfunction, Bone Health
- Being tested
- Dexa or Biompedance analysis with clinical and biochemical evaluations
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexa or Biompedance analysis with clinical and biochemical evaluationsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with pituitary disorders | Not described Receives: Diagnostic Test: Dexa or Biompedance analysis with clinical and biochemical evaluations | |
| patients without pituitary disorders | Not described Receives: Diagnostic Test: Dexa or Biompedance analysis with clinical and biochemical evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- Adipokines and obesity-associated cytokines serum content. c) Osteokines serum content.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; EndocrineStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, University of Catanzaro, Istituto Auxologico Italiano
- Responsible party
- Principal investigator, Andrea Giustina, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540820
- Sponsor's protocol ID
- PNRR-MCNT1-2023-12377758
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROENDOCRINE REGULATION OF BONE-FAT CROSSTALK IN OBESITY
- ClinicalTrials.gov ID
- NCT06540820
- Acronym / sponsor ID
- PNRR-MCNT1-2023-12377758
- Conditions
- Obesity; Endocrine, Pituitary Dysfunction, Bone Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Federico II University, University of Catanzaro, Istituto Auxologico Italiano
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effect of neuroendocrine dysfunctions on bone health in obesity
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Male and female subject <18-year-old
- pregnant or breastfeeding women
- Subject unable to sign informed consent
- BMI < 30 Kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexa or Biompedance analysis with clinical and biochemical evaluationsAll 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. | Diagnostic test | patients with pituitary disorders, patients without pituitary disorders |
Primary outcome
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: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity; Endocrine and Pituitary Dysfunction, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Giustina, professor (0226435062, giustina.andrea@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.