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Status unknownNCT04093947Updated Sep 18, 2019

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

An observational study in Hypertension and Obesity, sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. Status unknown at 1 site in Italy. Open to participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-18.

Sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
35 Years to 55 Years
Sex
All
01

Study 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.

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Conditions studied

  • Hypertension
  • Obesity
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In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's planned enrollment of 100 is below the median of 210 across 1,392 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis is the lead sponsor of 55 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 55 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherObservational study

    Observational and prospective study

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What researchers measure

Primary outcomes

  1. Insulin

    Insulin (mIU/L) concentration in serum

    Time frame: At baseline

  2. Potassium

    Potassium (mmol/L) concentration in serum

    Time frame: At baseline

  3. Sodium

    Sodium (mEq/L) concentration in serum

    Time frame: At baseline

  4. eGFR (estimated glomerular filtration rate)

    eGFR (ml/min/1.73 mq)

    Time frame: At baseline

  5. Creatinin

    Creatinin (mg/dl) concentration in serum

    Time frame: At baseline

  6. Uric acid

    Uric acid (mg/dL) concentration in serum

    Time frame: At baseline

  7. Total cholesterol

    Total cholesterol (mg/dL) concentrations in serum

    Time frame: At baseline

  8. Thyroid hormones (FT3, FT4)

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

    Time frame: At baseline

  9. HDL cholesterol

    HDL cholesterol (mg/dL) concentrations in serum

    Time frame: At baseline

  10. LDL cholesterol

    LDL cholesterol (mg/dL) concentrations in serum

    Time frame: At baseline

  11. Triglycerides

    Triglycerides (mg/dL) concentrations in serum

    Time frame: At baseline

  12. TSH

    TSH (mU/L) concentration in serum

    Time frame: At baseline

Secondary outcomes

  1. BMI

    BMI (kg/m\^2)

    Time frame: At baseline

  2. Height

    Height in meters

    Time frame: At baseline

  3. Weight

    Weight in kilograms

    Time frame: At baseline

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Study locations

1 site
  • National Institute of Gastroenterology IRCCS S. de Bellis
    Castellana Grotte, Bari 70013, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2019; primary completion for Oct 2020, 12 months later.

Of 446 non-industry observational studies under Hypertension, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 92. This study's planned 12 months is below that.

Counting every sponsor, half of 550 studies reached it within 44 months; a quarter within 19 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2019
First posted
Sep 18, 2019
StartEst.
Oct 1, 2019
Primary completionEst.
Oct 1, 2020
CompletionEst.
Oct 1, 2020
Last update
Sep 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04093947
Lead sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Responsible party
Gianluigi Giannelli (Clinical Professor, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis) — Principal investigator
First posted
Sep 18, 2019
Start date
Oct 1, 2019 (estimated)
Primary completion
Oct 1, 2020 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Sep 18, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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