Endocrine DisordersNCT06326853
Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models
An observational study of Endocrine Disorders and Adiposity, run by IRCCS San Raffaele.
Trial summary
The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine Disorders, Adiposity, Pituitary Adenoma
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients affected by: Non-secreting pituitary adenomas, Prolactinoma, Cushing's disease, Acromegaly, TSHomas, hypopituirarisms treated with cabergoline, octreotide, lanreotide, pasireotide, pegvisomant, rhGH and/or undergoing surgical therapy (transnasosphenoidal neurosurgical removal of the pituitary tumor. Healthy obese subjects.
Who may be able to join
- Obese patients affected and not by hypothalamic-pituitary diseases
Who cannot join
- Minor subjects;
- Pregnant and/or breastfeeding women;
- Patients suffering from states of primary and/or acquired immunodeficiencies, and/or serious impairment of general clinical conditions (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacerbated/compensated chronic pathologies);
- Patients unable to understand and sign the Informed Consent.
About this study
The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue
- Conditions
- Endocrine Disorders, Adiposity, Pituitary Adenoma, Cushing Syndrome, Acromegaly, Hypopituitarism
- Medical subject headings
- Endocrine System Diseases, Obesity, Pituitary Neoplasms, Cushing Syndrome, Acromegaly, Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients affected by hypothalamic-pituitary endocrine pathology | 100 patients affected by hypothalamic-pituitary endocrine pathology who have performed or who will perform a first visit at the Endocrinology Department of the San Raffaele Hospital between 01/01/2021 and 31/12/2026. | |
| affected by obesity | 100 patients affected by obesity who will perform a first visit at the Endocrinology Department of the San Raffaele Hospital between 01/01/2021 and 31/12/2026. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies
The study aims to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies
Measured: retrospective and prospective collection of clinical data between 01/01/2021 and 31/12/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine DisordersStudies 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Giustina, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326853
- Sponsor's protocol ID
- Adipofisi
- Status last verified
- Jun 2024
- First submitted
- 18 Mar 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models
- ClinicalTrials.gov ID
- NCT06326853
- Acronym / sponsor ID
- Adipofisi
- Conditions
- Endocrine Disorders, Adiposity, Pituitary Adenoma, Cushing Syndrome, Acromegaly, Hypopituitarism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Mar 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.
The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients affected by hypothalamic-pituitary endocrine pathology | – | –100 patients affected by hypothalamic-pituitary endocrine pathology who have performed or who will perform a first visit at the Endocrinology Department of the San Raffaele Hospital between 01/01/2021 and 31/12/2026. |
| affected by obesity | – | –100 patients affected by obesity who will perform a first visit at the Endocrinology Department of the San Raffaele Hospital between 01/01/2021 and 31/12/2026. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by: Non-secreting pituitary adenomas, Prolactinoma, Cushing's disease, Acromegaly, TSHomas, hypopituirarisms treated with cabergoline, octreotide, lanreotide, pasireotide, pegvisomant, rhGH and/or undergoing surgical therapy (transnasosphenoidal neurosurgical removal of the pituitary tumor. Healthy obese subjects.
Key inclusion criteria (1 listed)
- Obese patients affected and not by hypothalamic-pituitary diseases
Key exclusion criteria (4 listed)
- Minor subjects;
- Pregnant and/or breastfeeding women;
- Patients suffering from states of primary and/or acquired immunodeficiencies, and/or serious impairment of general clinical conditions (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacerbated/compensated chronic pathologies);
- Patients unable to understand and sign the Informed Consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies
Time frame: retrospective and prospective collection of clinical data between 01/01/2021 and 31/12/2026
The study aims to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disorders and Adiposity, 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 1 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: opening soon, as of the sponsor's last update on 11 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies (time frame: retrospective and prospective collection of clinical data between 01/01/2021 and 31/12/2026). 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 11 Jun 2024.