PRecisiOn MEdicine to Target Frailty of Endocrine-metabolic Origin

NCT04856683 | Unknown

• 1 other identifier: PROMETEO
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, observational, retrospective and prospective study for the evaluation of precision medicine to target frailty of endocrine-metabolic origin, with a genetic study.

Conditions

Frailty

Keywords

Adrenal disorders; Gonadal disorders; Type 2 diabetes mellitus; Pituitary disorders; Bone disorders; Biostatistics/bioinformatics

Outcome Measures

Primary Outcomes (2)

• Composite Clinical Score

  To derive a Composite Clinical Score able to identify endocrine fragile patients (occurrence of at least one of the following events: falls, disability, hospitalization, and mortality within the previous 18-months).

  Baseline

• Prediction of frailty

  Validation of Composite Clinical Score to predict frailty occurrence

  Baseline

Secondary Outcomes (14)

• Peripheral blood mononuclear cell subpopulations

  Baseline

• Molecular profiling

  Baseline

• Steroid profiling

  Baseline

• Measure of vascular flows though contrast enhanced ultrasound in endocrine glands

  Baseline

• Measure of liver vascular inflow through 4 dimensional (4D)-flow MRI

  Baseline

Study Arms (1)

Patients with endocrine and metabolic diseases

Patients with endocrine and metabolic diseases (hypothalamic-pituitary-gonadal and adrenal diseases, type 2 diabetes mellitus and bone diseases)

Eligibility Criteria

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

Study Population

Patients with endocrine and metabolic diseases (hypothalamic-pituitary-gonadal and adrenal diseases, type 2 diabetes mellitus and bone diseases). Retrospective cohort of 1100 subjects randomly selected from the 2000 on-file, after matching inclusion criteria. Prospective cohort of 378 subjects from the 1100 patients recruited in the retrospective phase.

You may qualify if:

• presence of endocrine and metabolic diseases (hypothalamic-pituitary-gonadal and adrenal diseases, type 2 diabetes mellitus, and bone diseases);
• signed informed consent to participate in the study.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (5)

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

Ospedale San Giovanni Calibita-Fatebenefratelli Fondazione Fatebenefratelli per la Ricerca e la Formazione Sanitaria e Sociale

Rome, 00186, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Senese

Siena, 53100, Italy

RECRUITING

Related Publications (55)

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MeSH Terms

Conditions

Frailty; Adrenal Gland Diseases; Gonadal Disorders; Diabetes Mellitus, Type 2; Pituitary Diseases; Bone Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases

Study Officials

• Andrea M Isidori, Prof

  Department of Experimental Medicine, "Sapienza" University of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea M Isidori, Prof

CONTACT

0039649972603; andrea.isidori@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 23, 2021
• Study Start: August 10, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 9, 2024
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

IT (5)