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
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.
- 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