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Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate

Changes Induced by Bariatric Surgery in Cardiovascular Responses to Dietary Supplementation With Sodium Nitrate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06303830
Enrollment
30
Registered
2024-03-12
Start date
2019-04-16
Completion date
2021-10-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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.

Interventions

DIETARY_SUPPLEMENTSodium nitrate

Sodium Nitrate

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Assess changes in s-nitrosothiols14 daysChange in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment

Secondary

MeasureTime frameDescription
Assess changes in blood pressure14 daysChange in Blood Pressure After Sodium Nitrate Treatment by Ambulatory blood pressure monitors (ABPMs)
Assess changes in endotelial function14 daysChange in endotelial function After Sodium Nitrate Treatment by Endopat
Assess changes in Vascular stiffness14 daysChange in Vascular stiffness After Sodium Nitrate Treatment by pulse wave velocity (PWV)
Assess changes in nitrate concentration14 daysChange in nitrate concentration in plasma After Sodium Nitrate Treatment
Assess changes in nitrite concentration14 daysChange in nitrite concentration in plasma After Sodium Nitrate Treatment

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026