Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension

• Conditions: Obesity; Hypertension

• Registration Number: NCT04093947
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief Summary

The study aims to investigate the characteristics of subjects with hypertension at onset among a cohort of apparently healthy subjects, with overweight or obesity (BMI ≥ 25 Kg / m2), and free of any drug treatment at the baseline. The evaluation includes anthropometric (weight, height, BMI, waist circumference), haematochemical (hormones, metabolic and routine) parameters and the screening for hypertension with ABPM. The diagnosis of hypertension is made in accordance with the 2017 guidelines of the American College of Cardiology / American Heart Association ACC / AHA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-27
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-17
• Last Update Submitted: 2019-09-17
• Study First Posted: 2019-09-18
• Last Update Posted: 2019-09-18
• Study Start: 2019-10-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)	At baseline	FT3 (pg/mL), FT4 (pg/mL) concentration in serum
HDL cholesterol	At baseline	HDL cholesterol (mg/dL) concentrations in serum
Potassium	At baseline	Potassium (mmol/L) concentration in serum
Creatinin	At baseline	Creatinin (mg/dl) concentration in serum
Total cholesterol	At baseline	Total cholesterol (mg/dL) concentrations in serum
Insulin	At baseline	Insulin (mIU/L) concentration in serum
Triglycerides	At baseline	Triglycerides (mg/dL) concentrations in serum
TSH	At baseline	TSH (mU/L) concentration in serum
Sodium	At baseline	Sodium (mEq/L) concentration in serum
LDL cholesterol	At baseline	LDL cholesterol (mg/dL) concentrations in serum
eGFR (estimated glomerular filtration rate)	At baseline	eGFR (ml/min/1.73 mq)
Uric acid	At baseline	Uric acid (mg/dL) concentration in serum

Secondary Outcome Measures

Name	Time	Method
Weight	At baseline	Weight in kilograms
BMI	At baseline	BMI (kg/m\^2)
Height	At baseline	Height in meters

Trial Locations

Locations (1)

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