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Completed

NCT Number: NCT06303830

Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão

Ribeirão Preto, São Paulo, 14.048-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Sodium nitrate

Dietary Supplement

Sodium Nitrate

Primary outcomes

  1. Assess changes in s-nitrosothiols

    Time frame: 14 days

    Change in s-nitrosothiols concentration in plasma After Sodium Nitrate Treatment

Secondary outcomes

  1. Assess changes in blood pressure

    Time frame: 14 days

    Change in Blood Pressure After Sodium Nitrate Treatment by Ambulatory blood pressure monitors (ABPMs)

  2. Assess changes in endotelial function

    Time frame: 14 days

    Change in endotelial function After Sodium Nitrate Treatment by Endopat

  3. Assess changes in Vascular stiffness

    Time frame: 14 days

    Change in Vascular stiffness After Sodium Nitrate Treatment by pulse wave velocity (PWV)

  4. Assess changes in nitrate concentration

    Time frame: 14 days

    Change in nitrate concentration in plasma After Sodium Nitrate Treatment

  5. Assess changes in nitrite concentration

    Time frame: 14 days

    Change in nitrite concentration in plasma After Sodium Nitrate Treatment

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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