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CompletedNCT06303830Updated Mar 12, 2024

Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate

An interventional study of Sodium nitrate in Hypertension, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled Apr 2019, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Female
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Study 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 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 4,996 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • For volunteers who underwent bariatric surgery:

    1. Female;
    2. Age over 18 years old and under 60 years old;
    3. Having had bariatric surgery more than 1 and a half years ago;
    4. Present stabilized weight loss;
  • For voluntary controls:

    1. Female;
    2. Age over 18 years old and under 60 years old;

Exclusion criteria

Exclusion Criteria:

  • For volunteers who underwent bariatric surgery and controls:

    1. Having uncontrolled blood pressure (above 160/100 mmHg), even with use regulate up to two antihypertensive agents;
    2. Hypertensive patients must be using a maximum of two antihypertensives;
    3. Have Diabetes Mellitus or other endocrinopathy;
    4. Have kidney or liver failure;
    5. Individuals who smoke.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Control group

    Sodium nitrate, once a day for 14 days

    Dietary Supplement: Sodium nitrate

  • Experimental
    Bariatric group

    Sodium nitrate, once a day for 14 days

    Dietary Supplement: Sodium nitrate

Interventions

  • Dietary supplementSodium nitrate

    Sodium Nitrate

06

What researchers measure

Primary outcomes

  1. Assess changes in s-nitrosothiols

    Change in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment

    Time frame: 14 days

Secondary outcomes

  1. Assess changes in blood pressure

    Change in Blood Pressure After Sodium Nitrate Treatment by Ambulatory blood pressure monitors (ABPMs)

    Time frame: 14 days

  2. Assess changes in endotelial function

    Change in endotelial function After Sodium Nitrate Treatment by Endopat

    Time frame: 14 days

  3. Assess changes in Vascular stiffness

    Change in Vascular stiffness After Sodium Nitrate Treatment by pulse wave velocity (PWV)

    Time frame: 14 days

  4. Assess changes in nitrate concentration

    Change in nitrate concentration in plasma After Sodium Nitrate Treatment

    Time frame: 14 days

  5. Assess changes in nitrite concentration

    Change in nitrite concentration in plasma After Sodium Nitrate Treatment

    Time frame: 14 days

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Study locations

1 site
  • Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão
    Ribeirão Preto, São Paulo 14.048-900, Brazil
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06303830
Lead sponsor
University of Sao Paulo
Responsible party
Jéssica Maria Sanches Lopes (PhD in Pharmacology, University of Sao Paulo) — Principal investigator
First posted
Mar 12, 2024
Start date
Apr 16, 2019
Primary completion
Dec 17, 2020
Completion
Oct 1, 2021
Last update
Mar 12, 2024

Oversight

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

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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