Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Sodium nitrate

• Registration Number: NCT06303830
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-16
• Primary Completion: 2020-12-17
• Study Completion: 2021-10-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bariatric group	Sodium nitrate	Sodium nitrate, once a day for 14 days
Control group	Sodium nitrate	Sodium nitrate, once a day for 14 days

Primary Outcome Measures

Name	Time	Method
Assess changes in s-nitrosothiols	14 days	Change in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment

Secondary Outcome Measures

Name	Time	Method
Assess changes in Vascular stiffness	14 days	Change in Vascular stiffness After Sodium Nitrate Treatment by pulse wave velocity (PWV)
Assess changes in blood pressure	14 days	Change in Blood Pressure After Sodium Nitrate Treatment by Ambulatory blood pressure monitors (ABPMs)
Assess changes in nitrate concentration	14 days	Change in nitrate concentration in plasma After Sodium Nitrate Treatment
Assess changes in nitrite concentration	14 days	Change in nitrite concentration in plasma After Sodium Nitrate Treatment
Assess changes in endotelial function	14 days	Change in endotelial function After Sodium Nitrate Treatment by Endopat

Trial Locations

Locations (1)

Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão; 🇧🇷 Ribeirão Preto, São Paulo, Brazil