HypertensionNCT04093947
Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension
An observational study of Hypertension and Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- Observational study
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Overweight or obesity (BMI> 25 Kg/m2)
Who cannot join
- Any kind of drug
- Hypertension
- Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
- Chronic inflammatory diseases
- Renal failure
- Liver failure
Show all 10Show fewer
- Angina pectoris
- Myocardial infarction and heart failure
- Genetic heart diseases
- Thrombocytopenias
Trial locations and contacts
1 site in 1 country.
Italy1 site
National Institute of Gastroenterology IRCCS S. de Bellis
Castellana Grotte, Bari, 70013
About this study
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
- Being tested
- Observational study
- Medical subject headings
- Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational and prospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin
Insulin (mIU/L) concentration in serum
Measured: At baseline
Potassium
Potassium (mmol/L) concentration in serum
Measured: At baseline
Sodium
Sodium (mEq/L) concentration in serum
Measured: At baseline
eGFR (estimated glomerular filtration rate)
eGFR (ml/min/1.73 mq)
Measured: At baseline
Creatinin
Creatinin (mg/dl) concentration in serum
Measured: At baseline
Uric acid
Uric acid (mg/dL) concentration in serum
Measured: At baseline
Total cholesterol
Total cholesterol (mg/dL) concentrations in serum
Measured: At baseline
Thyroid hormones (FT3, FT4)
FT3 (pg/mL), FT4 (pg/mL) concentration in serum
Measured: At baseline
HDL cholesterol
HDL cholesterol (mg/dL) concentrations in serum
Measured: At baseline
LDL cholesterol
LDL cholesterol (mg/dL) concentrations in serum
Measured: At baseline
Triglycerides
Triglycerides (mg/dL) concentrations in serum
Measured: At baseline
TSH
TSH (mU/L) concentration in serum
Measured: At baseline
Secondary outcomes (3)
BMI
BMI (kg/m^2)
Measured: At baseline
Height
Height in meters
Measured: At baseline
Weight
Weight in kilograms
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093947
- Sponsor's protocol ID
- prot2019
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension
- ClinicalTrials.gov ID
- NCT04093947
- Acronym / sponsor ID
- prot2019
- Conditions
- Hypertension, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Overweight or obesity (BMI> 25 Kg/m2)
Key exclusion criteria (10 listed)
- Any kind of drug
- Hypertension
- Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
- Chronic inflammatory diseases
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyObservational and prospective study | Other | – |
Primary outcome
Insulin
Time frame: At baseline
Insulin (mIU/L) concentration in serum
Potassium
Time frame: At baseline
Potassium (mmol/L) concentration in serum
Sodium
Time frame: At baseline
Sodium (mEq/L) concentration in serum
eGFR (estimated glomerular filtration rate)
Time frame: At baseline
eGFR (ml/min/1.73 mq)
Creatinin
Time frame: At baseline
Creatinin (mg/dl) concentration in serum
Uric acid
Time frame: At baseline
Uric acid (mg/dL) concentration in serum
Total cholesterol
Time frame: At baseline
Total cholesterol (mg/dL) concentrations in serum
Thyroid hormones (FT3, FT4)
Time frame: At baseline
FT3 (pg/mL), FT4 (pg/mL) concentration in serum
HDL cholesterol
Time frame: At baseline
HDL cholesterol (mg/dL) concentrations in serum
LDL cholesterol
Time frame: At baseline
LDL cholesterol (mg/dL) concentrations in serum
Triglycerides
Time frame: At baseline
Triglycerides (mg/dL) concentrations in serum
TSH
Time frame: At baseline
TSH (mU/L) concentration in serum
3 secondary outcomes
BMI
Time frame: At baseline
Height
Time frame: At baseline
Weight
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin (time frame: At baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.