Phase 2
Completed N=20
Oral Nitrite in Adults With Metabolic Syndrome and Hypertension
Source: ClinicalTrials.gov NCT01681810 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Change in Insulin Stimulated Glucose Disposal Over 12 Week Study Period — 0.76 mg/kg lean body mass/minute — p=0.2068
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Stimulated Glucose Disposal Over 12 Week Study Period |
0.76 | 0.2068 |
| SECONDARY Peak Change in Systolic Blood Pressure Over 12 Week Study Period |
-10.45 | 0.0074 sig |
| SECONDARY Peak Change in Diastolic Blood Pressure Over 12 Week Study Period |
-13.05 | <0.0001 sig |
| SECONDARY Peak Change in Mean Arterial Pressure Over 12 Week Study Period |
-12.00 | <0.0001 sig |
| SECONDARY Peak Change in Methemoglobin Over 12 Week Study Period |
0.42 | 0.0127 sig |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01681810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.