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

NCT04093947 | Unknown

• 1 other identifier: prot2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obesity

Outcome Measures

Primary Outcomes (12)

• Insulin

  Insulin (mIU/L) concentration in serum

  At baseline

• Potassium

  Potassium (mmol/L) concentration in serum

  At baseline

• Sodium

  Sodium (mEq/L) concentration in serum

  At baseline

• eGFR (estimated glomerular filtration rate)

  eGFR (ml/min/1.73 mq)

  At baseline

• Creatinin

  Creatinin (mg/dl) concentration in serum

  At baseline

• Uric acid

  Uric acid (mg/dL) concentration in serum

  At baseline

• Total cholesterol

  Total cholesterol (mg/dL) concentrations in serum

  At baseline

• Thyroid hormones (FT3, FT4)

  FT3 (pg/mL), FT4 (pg/mL) concentration in serum

  At baseline

• HDL cholesterol

  HDL cholesterol (mg/dL) concentrations in serum

  At baseline

• LDL cholesterol

  LDL cholesterol (mg/dL) concentrations in serum

  At baseline

• Triglycerides

  Triglycerides (mg/dL) concentrations in serum

  At baseline

• TSH

  TSH (mU/L) concentration in serum

  At baseline

Secondary Outcomes (3)

• BMI

  At baseline

• Height

  At baseline

• Weight

  At baseline

Interventions

Observational study OTHER

Observational and prospective study

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

National Institute of Gastroenterology IRCCS S. de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

Observation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 18, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)