24-hour Urinary Aldosterone And Endocrine System In Obesity

NCT ID: NCT04354285

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-01

Brief Summary

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The study was aimed at investigating the relationship between hormone parameters and urinary aldosterone levels in 24h within a cohort of overweight and obesity.

Detailed Description

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Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP) and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Observational

Observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role lead

Responsible Party

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Gianluigi Giannelli

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, Italy

Site Status

Countries

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Italy

Other Identifiers

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5/2020

Identifier Type: -

Identifier Source: org_study_id

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