Oral Nitrite Trial for Hypertension and Metabolic Syndrome

• Status: Withdrawn
• Trial end date: 2021-04-13
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to investigate effects of inorganic sodium nitrite on the cardiometabolic and hormonal disturbances observed in a targeted population of overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin resistance and endothelial dysfunction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gladwin, Mark, MD; University of Pittsburgh

Criteria

Inclusion Criteria:

• Age 18-60 years

• Body mass index (BMI) ≥ 30 kg/m2

• Hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure ≥85 mm Hg

• Waist circumference: >102 cm in men, >88 cm in women

Exclusion Criteria:

• Positive urine pregnancy test or breastfeeding

• Concurrent use of medications affecting glucose metabolism (oral hypoglycemics, insulin, atypical antipsychotics)

• Recent addition or change in dosing of hormonal contraceptive medications (Oral Contraceptive Pill (OCP), Intra Uterine Device (IUD), DepoProvera shot)

• Current use of ≥3 anti-hypertensive agents regardless of blood pressure control or normotensive on a single or double agent

• Current use of phosphodiesterase-5 (PD) inhibitors or organic nitrates. We will not exclude for dietary sources of nitrate/nitrite.

• Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc.

• Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes

• Thyroid Stimulating Hormone (TSH) >8 milli-International unit/mL

• Smoker

• Anemia (central lab hemoglobin < 11g/dL)

• Active periodontal disease