RecruitingNot Applicable

Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes

United States24 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (\<1 day/week of structured exercise) * Be able to perform exercise on a cycle ergometer without assistance * Stable medication regimen for the last 6 months * If female, have a normal menstrual cycle Exclusion Criteria: * Estimated Glomerular filtration rate (GFR) ≤ 45 * Body mass index ≥ 40 Kg/m2 * HbA1c \> 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 wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vascular Endothelial Function (Pulse wave analysis and velocity [PWA/V])

Timeframe: 3 days following either active NO3 or placebo without nitrate (following 7-day washout).

Vascular Endothelial Function (Flow-Mediated Dilation [FMD])

Timeframe: 3 days following either active NO3 or placebo without nitrate (following 7-day washout).

Skin microvascular function using post-occlusive reactive hyperemia (PORH)

Timeframe: 3 days following either active NO3 or placebo without nitrate (following 7-day washout)

Skin microvascular function: Change in Skin Microvascular Dilation in Response to Local Thermal Heating

Timeframe: 3 days following either active NO3 or placebo without nitrate (following 7-day washout).

Skin microvascular function: Change in microvascular dilation in response to acetylcholine (ACh)

Timeframe: 3 days following either active NO3 or placebo without nitrate (following 7-day washout)

Oral Glucose Tolerance Test (OGTT)

Timeframe: 3 days following either active NO3 or placebo without nitrate (following 7-day washout).

Trial details

NCT IDNCT07131384

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Money Ghimire, M.S

4342438677 eta8xd@uvahealth.org

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