Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate
Changes Induced by Bariatric Surgery in Cardiovascular Responses to Dietary Supplementation With Sodium Nitrate
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Apr 2019
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedMarch 12, 2024
March 1, 2024
1.7 years
March 4, 2024
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Assess changes in s-nitrosothiols
Change in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment
14 days
Secondary Outcomes (5)
Assess changes in blood pressure
14 days
Assess changes in endotelial function
14 days
Assess changes in Vascular stiffness
14 days
Assess changes in nitrate concentration
14 days
Assess changes in nitrite concentration
14 days
Study Arms (2)
Control group
ACTIVE COMPARATORSodium nitrate, once a day for 14 days
Bariatric group
EXPERIMENTALSodium nitrate, once a day for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- For volunteers who underwent bariatric surgery:
- Female;
- Age over 18 years old and under 60 years old;
- Having had bariatric surgery more than 1 and a half years ago;
- Present stabilized weight loss;
- For voluntary controls:
- Female;
- Age over 18 years old and under 60 years old;
You may not qualify if:
- For volunteers who underwent bariatric surgery and controls:
- Having uncontrolled blood pressure (above 160/100 mmHg), even with use regulate up to two antihypertensive agents;
- Hypertensive patients must be using a maximum of two antihypertensives;
- Have Diabetes Mellitus or other endocrinopathy;
- Have kidney or liver failure;
- Individuals who smoke.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão
Ribeirão Preto, São Paulo, 14.048-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD in Pharmacology
Study Record Dates
First Submitted
March 4, 2024
First Posted
March 12, 2024
Study Start
April 16, 2019
Primary Completion
December 17, 2020
Study Completion
October 1, 2021
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share