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Not yet recruitingNCT06326853Updated Jun 11, 2024

Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models

An observational study in Endocrine Disorders, Adiposity and Pituitary Adenoma, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Endocrine Disorders
  • Adiposity
  • Pituitary Adenoma
  • Cushing Syndrome
  • Acromegaly
  • Hypopituitarism
03

In context

Endocrine System Diseases

312 studies on the registry are indexed under Endocrine System Diseases; 53 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 86 observational studies indexed under Endocrine System Diseases.

Browse Endocrine System Diseases studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 450 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Obese patients affected and not by hypothalamic-pituitary diseases

Exclusion criteria

Exclusion Criteria:

  1. Minor subjects;
  2. Pregnant and/or breastfeeding women;
  3. 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);
  4. Patients unable to understand and sign the Informed Consent.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: retrospective and prospective collection of clinical data between 01/01/2021 and 31/12/2026

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06326853
Lead sponsor
IRCCS San Raffaele
Responsible party
Andrea Giustina (Professor of Endocrinology and Metabolism, IRCCS San Raffaele) — Principal investigator
First posted
Mar 22, 2024
Start date
Jul 2024 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 11, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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