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

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ClinicalTrials.gov Identifier: NCT04093947
Recruitment Status : Not yet recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluigi Giannelli, 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.

Condition or disease Intervention/treatment
Hypertension Obesity Other: Observational study

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Observational study
    Observational and prospective study


Primary Outcome Measures :
  1. Insulin [ Time Frame: At baseline ]
    Insulin (mIU/L) concentration in serum

  2. Potassium [ Time Frame: At baseline ]
    Potassium (mmol/L) concentration in serum

  3. Sodium [ Time Frame: At baseline ]
    Sodium (mEq/L) concentration in serum

  4. eGFR (estimated glomerular filtration rate) [ Time Frame: At baseline ]
    eGFR (ml/min/1.73 mq)

  5. Creatinin [ Time Frame: At baseline ]
    Creatinin (mg/dl) concentration in serum

  6. Uric acid [ Time Frame: At baseline ]
    Uric acid (mg/dL) concentration in serum

  7. Total cholesterol [ Time Frame: At baseline ]
    Total cholesterol (mg/dL) concentrations in serum

  8. Thyroid hormones (FT3, FT4) [ Time Frame: At baseline ]
    FT3 (pg/mL), FT4 (pg/mL) concentration in serum

  9. HDL cholesterol [ Time Frame: At baseline ]
    HDL cholesterol (mg/dL) concentrations in serum

  10. LDL cholesterol [ Time Frame: At baseline ]
    LDL cholesterol (mg/dL) concentrations in serum

  11. Triglycerides [ Time Frame: At baseline ]
    Triglycerides (mg/dL) concentrations in serum

  12. TSH [ Time Frame: At baseline ]
    TSH (mU/L) concentration in serum


Secondary Outcome Measures :
  1. BMI [ Time Frame: At baseline ]
    BMI (kg/m^2)

  2. Height [ Time Frame: At baseline ]
    Height in meters

  3. Weight [ Time Frame: At baseline ]
    Weight in kilograms



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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093947


Locations
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Italy
National Institute of Gastroenterology IRCCS S. de Bellis
Castellana Grotte, Bari, Italy, 70013
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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Responsible Party: Gianluigi Giannelli, Clinical Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier: NCT04093947     History of Changes
Other Study ID Numbers: prot2019
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Obesity
Overweight
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms