Oral Nitrite in Adults With Metabolic Syndrome and Hypertension

Completed · Phase 2

Conditions studied: Metabolic Syndrome, Hypertension

In brief

This research study is being conducted to examine the effects of daily inorganic nitrite treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy may have a major impact on the prevention and treatment of both diabetes and cardiovascular disease.

Key facts

Study ID

NCT01681810

Run by

Gladwin, Mark, MD

People needed

20

Starts

2012-10-01

Expected to finish

2018-03-08

Last updated by the study team

2019-04-16

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) greater than or equal to 30 kg/m\^2
• Hypertension: defined as systolic blood pressure (SBP) greater than or equal to 130 and/or diastolic blood pressure (DBP) greater than or equal to 85 mm Hg
• Waist circumference: greater than 102 cm in men, greater than 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), intrauterine device (IUD), DepoProvera]
• Current use of greater than or equal to 3 anti-hypertensive agents regardless of blood pressure control or normotensive on a single or double agent
• Current use of phosphodiesterase-5 inhibitors or organic nitrates
• 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) greater than 8 milli-International unit/mL
• Smoker
• Anemia (central lab hemoglobin less than 11g/dL)

Where it is running

• Montefiore Hospital of University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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