Oral Nitrite in Adults With Metabolic Syndrome and Hypertension

• Status: Completed
• Trial end date: 2018-03-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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) 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

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), 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)