HypertensionNCT06303830
Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate
A study testing Sodium nitrate in people with Hypertension, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Sodium nitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Apr 2019to 1 Oct 2021
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For volunteers who underwent bariatric surgery:
- Female;
- Age over 18 years old and under 60 years old;
- Having had bariatric surgery more than 1 and a half years ago;
- Present stabilized weight loss;
- For voluntary controls:
- Female;
- Age over 18 years old and under 60 years old;
Who cannot join
- For volunteers who underwent bariatric surgery and controls:
- Having uncontrolled blood pressure (above 160/100 mmHg), even with use regulate up to two antihypertensive agents;
- Hypertensive patients must be using a maximum of two antihypertensives;
- Have Diabetes Mellitus or other endocrinopathy;
- Have kidney or liver failure;
- Individuals who smoke.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão
Ribeirão Preto, São Paulo, 14.048-900
About this study
Official title: Changes Induced by Bariatric Surgery in Cardiovascular Responses to Dietary Supplementation With Sodium Nitrate
Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with nitrite-reductase activity. The acidic environment of the stomach is very important to the formation of NO and S-nitrosothiols and several studies suggest that changes in gastric pH can affect this conversion. In this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric pH, can affect the nitrate-nitrite-NO pathway and change the antihypertensive and antioxidant effect of sodium nitrate.
- Conditions
- Hypertension
- Being tested
- Sodium nitrate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium nitrateDietary supplement
Sodium Nitrate
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Sodium nitrate, once a day for 14 days Receives: Dietary Supplement: Sodium nitrate |
| Bariatric group | Experimental | Sodium nitrate, once a day for 14 days Receives: Dietary Supplement: Sodium nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess changes in s-nitrosothiols
Change in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment
Measured: 14 days
Secondary outcomes (5)
Assess changes in blood pressure
Change in Blood Pressure After Sodium Nitrate Treatment by Ambulatory blood pressure monitors (ABPMs)
Measured: 14 days
Assess changes in endotelial function
Change in endotelial function After Sodium Nitrate Treatment by Endopat
Measured: 14 days
Assess changes in Vascular stiffness
Change in Vascular stiffness After Sodium Nitrate Treatment by pulse wave velocity (PWV)
Measured: 14 days
Assess changes in nitrate concentration
Change in nitrate concentration in plasma After Sodium Nitrate Treatment
Measured: 14 days
Assess changes in nitrite concentration
Change in nitrite concentration in plasma After Sodium Nitrate Treatment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start16 Apr 2019
- Primary completion17 Dec 2020
- Study completion1 Oct 2021
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jéssica Maria Sanches Lopes, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303830
- Sponsor's protocol ID
- BACA2019
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes Induced by Bariatric Surgery in Cardiovascular Responses to Dietary Supplementation With Sodium Nitrate
- ClinicalTrials.gov ID
- NCT06303830
- Acronym / sponsor ID
- BACA2019
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 12 Mar 2024 (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.
Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with nitrite-reductase activity. The acidic environment of the stomach is very important to the formation of NO and S-nitrosothiols and several studies suggest that changes in gastric pH can affect this conversion. In this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric pH, can affect the nitrate-nitrite-NO pathway and change the antihypertensive and antioxidant effect of sodium nitrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Dietary Supplement: Sodium nitrateSodium nitrate, once a day for 14 days |
| Bariatric group | Experimental | Dietary Supplement: Sodium nitrateSodium nitrate, once a day for 14 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- For volunteers who underwent bariatric surgery:
- For voluntary controls:
Key exclusion criteria (6 listed)
- For volunteers who underwent bariatric surgery and controls:
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 |
|---|---|---|
| Sodium nitrateSodium Nitrate | Dietary supplement | Bariatric group, Control group |
Primary outcome
Assess changes in s-nitrosothiols
Time frame: 14 days
Change in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment
5 secondary outcomes
Assess changes in blood pressure
Time frame: 14 days
Assess changes in endotelial function
Time frame: 14 days
Assess changes in Vascular stiffness
Time frame: 14 days
Assess changes in nitrate concentration
Time frame: 14 days
Assess changes in nitrite concentration
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- 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?
A study testing Sodium nitrate in people with Hypertension, run by University of Sao Paulo at 1 site in Brazil.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 12 Mar 2024. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess changes in s-nitrosothiols (time frame: 14 days). 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 12 Mar 2024.