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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06303830
Other study ID # BACA2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 16, 2019
Est. completion date October 1, 2021

Study information

Verified date March 2024
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 1, 2021
Est. primary completion date December 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Sodium nitrate
Sodium Nitrate

Locations

Country Name City State
Brazil Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Ribeirão Preto São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess changes in s-nitrosothiols Change in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment 14 days
Secondary Assess changes in blood pressure Change in Blood Pressure After Sodium Nitrate Treatment by Ambulatory blood pressure monitors (ABPMs) 14 days
Secondary Assess changes in endotelial function Change in endotelial function After Sodium Nitrate Treatment by Endopat 14 days
Secondary Assess changes in Vascular stiffness Change in Vascular stiffness After Sodium Nitrate Treatment by pulse wave velocity (PWV) 14 days
Secondary Assess changes in nitrate concentration Change in nitrate concentration in plasma After Sodium Nitrate Treatment 14 days
Secondary Assess changes in nitrite concentration Change in nitrite concentration in plasma After Sodium Nitrate Treatment 14 days
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