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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06326853
Other study ID # Adipofisi
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date December 2026

Study information

Verified date March 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2026
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Obese patients affected and not by hypothalamic-pituitary diseases 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.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Outcome

Type Measure Description Time frame Safety issue
Primary 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 retrospective and prospective collection of clinical data between 01/01/2021 and 31/12/2026
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