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

September 17, 2019 updated by: Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bari
      • Castellana Grotte, Bari, Italy, 70013
        • National Institute of Gastroenterology IRCCS S. de Bellis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: At baseline
BMI (kg/m^2)
At baseline
Height
Time Frame: At baseline
Height in meters
At baseline
Weight
Time Frame: At baseline
Weight in kilograms
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prot2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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