Trial reportDiabetes technology & therapeutics2012
Single-dose pharmacokinetics of different oral sodium nitrite formulations in diabetes patients.
Trial report in Diabetes technology & therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 43 citations in OpenAlex.
- Effects of Fermented Garlic Extract Containing Nitric Oxide Metabolites on Blood Flow in Healthy Participants: A Randomized Controlled Trial.Nutrients · 2022Trial
- Inorganic Nitrite Supplementation Improves Endothelial Function With Aging: Translational Evidence for Suppression of Mitochondria-Derived Oxidative Stress.Hypertension (Dallas, Tex. : 1979) · 2021Trial
- Simultaneous Pharmacokinetic Analysis of Nitrate and its Reduced Metabolite, Nitrite, Following Ingestion of Inorganic Nitrate in a Mixed Patient Population.Pharmaceutical research · 2020Trial
- Effects of sodium nitrite supplementation on vascular function and related small metabolite signatures in middle-aged and older adults.Journal of applied physiology (Bethesda, Md. : 1985) · 2016Trial
- A novel hydrogen sulfide prodrug, SG1002, promotes hydrogen sulfide and nitric oxide bioavailability in heart failure patients.Cardiovascular therapeutics · 2015Trial
- Higher salivary nitrite is associated with improved glycemic control and insulin sensitivity in patients with type 2 diabetes.Nutrition & metabolism · 2026Article
- From nitrate to NO: potential effects of nitrate-reducing bacteria on systemic health and disease.European journal of medical research · 2023Review
- Supplemental nitrite increases choroidal neovascularization in mice.Nitric oxide : biology and chemistry · 2021Article
- Safety and toxicology assessment of sodium nitrite administered by intramuscular injection.Toxicology and applied pharmacology · 2021Article
- Lost-in-Translation of Metabolic Effects of Inorganic Nitrate in Type 2 Diabetes: Is Ascorbic Acid the Answer?International journal of molecular sciences · 2021Review
- Does the Oral Microbiome Play a Role in Hypertensive Pregnancies?Frontiers in cellular and infection microbiology · 2020Review
- Update on Gaseous Signaling Molecules Nitric Oxide and Hydrogen Sulfide: Strategies to Capture their Functional Activity for Human Therapeutics.Molecular pharmacology · 2019Review
- Nitrite and nitrate chemical biology and signalling.British journal of pharmacology · 2019Review
- Review
- Functional Nitric Oxide Nutrition to Combat Cardiovascular Disease.Current atherosclerosis reports · 2018Review
- Effect of sodium nitrite on local control of contracting skeletal muscle microvascular oxygen pressure in healthy rats.Journal of applied physiology (Bethesda, Md. : 1985) · 2017Article
- Consumption of nitrate-containing vegetables is inversely associated with hypertension in adults: a prospective investigation from the Tehran Lipid and Glucose Study.Journal of nephrology · 2016Article
- The Nitrate-Nitrite-NO Pathway and Its Implications for Heart Failure and Preserved Ejection Fraction.Current heart failure reports · 2016Review
- Beneficial effects of inorganic nitrate/nitrite in type 2 diabetes and its complications.Nutrition & metabolism · 2015Article
- Topical sodium nitrite for chronic leg ulcers in patients with sickle cell anaemia: a phase 1 dose-finding safety and tolerability trial.The Lancet. Haematology · 2014Article
Corrections and comments
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Authors and funding
9 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundDiabetic foot ulcers, although associated with macrovascular disease and neuropathy, have a microvascular disease causing ischemia not amenable to surgical intervention. Nitrite selectively releases nitric oxide in ischemic tissues, and diabetes subjects have low nitrite levels that do not increase with exercise. This study explores the safety and pharmacokinetics of a single dose of sodium nitrite in subjects with diabetic foot ulcers. SUBJECTS AND
methodsUsing a blinded, randomized crossover study design, 12 subjects with diabetes mellitus and active or healed foot ulcers received a single dose of sodium nitrite on two occasions 7-28 days apart, once with an immediate release (IR) formulation and once with an enteric-coated (EC) formulation for delayed release. Serum nitrite, nitrate, methemoglobin, sulfhemoglobin, blood pressure, pulse rate, complete blood count, chemistry panel, electrocardiogram, and adverse events were followed for up to 6 h after each dose. The IR and EC nitrite levels were analyzed by one-way analysis of variance and by pharmacokinetic modeling.
resultsThe IR formulation elevated nitrite levels between 0.25 and 0.75 h (P<0.05). The EC formulation did not elevate nitrite levels significantly, but both formulations gave plasma nitrite levels previously suggested to be therapeutic (approximately 2-5 μM). The IR formulation gave an asymptomatic blood pressure drop of 10/6 mm Hg (P<0.003), and two subjects experienced mild flushing. There was no elevation of methemoglobin or other safety concerns. Pharmacokinetic modeling of plama nitrite levels gave r(2) values of 0.81 and 0.97 for the fits for IR and EC formulations, respectively.
conclusionsOral sodium nitrite administration is well tolerated in diabetes patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.