24-hour Urinary Aldosterone And Endocrine System In Obesity

Completed

• Conditions: Obesity

• Registration Number: NCT04354285
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thyroid hormones (FT3, FT4)	Baseline	FT3 (pg/mL), FT4 (pg/mL) concentration in serum
TSH	Baseline	TSH (mU/L) concentration in serum
Urinary Aldosterone	Baseline	24-h Urine Aldosterone (mg/24 h)
Prolactin	Baseline	Prolactin (ng/ml) concentration in serum
Insulin	Baseline	Insulin (mIU/L) concentration in serum
Parathyroid Hormone	Baseline	PTH (pg/mL) concentration in serum

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	Baseline	Total cholesterol (mg/dL) concentrations in serum
HDL cholesterol	Baseline	HDL cholesterol (mg/dL) concentrations in serum
LDL cholesterol	Baseline	LDL cholesterol (mg/dL) concentrations in serum
BMI	Baseline	BMI (kg/m\^2)
Height	Baseline	Height in meters
Weight	Baseline	Weight in kilograms
Vitamin D	Baseline	Vitamin D (ng/mL) concentration in serum

Trial Locations

Locations (1)

National Institute of Gastroenterology IRCCS S. de Bellis; 🇮🇹 Castellana Grotte, Bari, Italy