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Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate

U

University of Sao Paulo

Status

Completed

Conditions

Hypertension

Treatments

Dietary Supplement: Sodium nitrate

Study type

Interventional

Funder types

Other

Identifiers

NCT06303830
BACA2019

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Control group
Active Comparator group
Description:
Sodium nitrate, once a day for 14 days
Treatment:
Dietary Supplement: Sodium nitrate
Bariatric group
Experimental group
Description:
Sodium nitrate, once a day for 14 days
Treatment:
Dietary Supplement: Sodium nitrate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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