Oral Nitrite Trial for Hypertension and Metabolic Syndrome

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Metabolic Syndrome, Hypertension

In brief

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.

Key facts

Study ID

NCT02517697

Run by

Gladwin, Mark, MD

People needed

0

Starts

2020-10-01

Expected to finish

2021-04-13

Last updated by the study team

2021-04-19

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montefiore Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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