Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06303830
• Other study ID #: BACA2019
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hypertension

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