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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093947
• Other study ID #: prot2019
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2019
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Overweight

Intervention

Other:
• Observational study
Observational and prospective study

Locations

Country	Name	City	State
Italy	National Institute of Gastroenterology IRCCS S. de Bellis	Castellana Grotte	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin	Insulin (mIU/L) concentration in serum	At baseline
Primary	Potassium	Potassium (mmol/L) concentration in serum	At baseline
Primary	Sodium	Sodium (mEq/L) concentration in serum	At baseline
Primary	eGFR (estimated glomerular filtration rate)	eGFR (ml/min/1.73 mq)	At baseline
Primary	Creatinin	Creatinin (mg/dl) concentration in serum	At baseline
Primary	Uric acid	Uric acid (mg/dL) concentration in serum	At baseline
Primary	Total cholesterol	Total cholesterol (mg/dL) concentrations in serum	At baseline
Primary	Thyroid hormones (FT3, FT4)	FT3 (pg/mL), FT4 (pg/mL) concentration in serum	At baseline
Primary	HDL cholesterol	HDL cholesterol (mg/dL) concentrations in serum	At baseline
Primary	LDL cholesterol	LDL cholesterol (mg/dL) concentrations in serum	At baseline
Primary	Triglycerides	Triglycerides (mg/dL) concentrations in serum	At baseline
Primary	TSH	TSH (mU/L) concentration in serum	At baseline
Secondary	BMI	BMI (kg/m^2)	At baseline
Secondary	Height	Height in meters	At baseline
Secondary	Weight	Weight in kilograms	At baseline