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

NCT06326853 | Not Yet Recruiting

• 1 other identifier: Adipofisi
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Endocrine Disorders; Adiposity; Pituitary Adenoma; Cushing Syndrome; Acromegaly; Hypopituitarism

Outcome Measures

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

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Obese patients affected and not by hypothalamic-pituitary diseases

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Endocrine System Diseases; Obesity; Pituitary Neoplasms; Cushing Syndrome; Acromegaly; Hypopituitarism

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinology and Metabolism

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 22, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06