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NCT07131384
Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes
Conditions: Males, Females, Sedentary, Metformin, Prediabetes
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: University of Virginia
Location: University of Virginia Charlottesville Virginia
Summary
This study is examining whether short-term supplementation with inorganic nitrate, in the form of beetroot juice, can enhance blood vessel health, insulin sensitivity, and exercise capacity in individuals with prediabetes. We will be comparing the responses in individuals who are taking metformin to those who are naive to metformin. The results from this study may help identify non-pharmacological interventions in prediabetes.
Eligibility Criteria
Inclusion Criteria:
* Individuals who can communicate meaningfully with the investigator and can provide written consent.
* Confirmed prediabetic individuals (ages 18-60 years old) (2-hour glucose of 140-199 mg/dL following OGTT test or HbA1c between 5.7-6.4% tested on two occasions within 6 months).
* Taking metformin (stable dose for at least a week) or naïve to metformin
* Sedentary (\ 6.4%
* Smokers within the last 5 years
* Has experienced significant weight loss \~3 kg in the last three months or is taking any weight loss drugs
* Current medical condition that prohibits exercising at high intensities
* Currently on hormone replacement of any kind
* History of myocardial infarction, cerebrovascular event, acute or unstable disease other than pre-diabetes or obesity
* Currently taking any of the following medications (calcium channel blockers, statins, ACE or renin inhibitors, angiotensin receptor blockers, organic nitrates (e.g., nitroglycerine) or recent regular use of inorganic nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, PDE-5 inhibitors (e.g.,: Cialis, Viagra), or xanthine oxidase inhibitors (e.g.,: Allopurinol))
* Oral antibiotic use within the previous four weeks, including over-the-counter antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
* Oral cancer/severe oral disease
* Uncontrolled hypertension (\>140/90)
* Had hysterectomy or oophorectomy
* Fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking participants
Source: ClinicalTrials.gov (NCT07131384). StuddyBuddy aggregates publicly available trial information.
