Not Yet RecruitingNot Applicable

Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes

24 participantsStarted 2025-09-01

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 range18 Years – 60 Years

SexALL

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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…

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).

Plasma Nitrate/Nitrite

Trial details

NCT IDNCT07131384

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Money Ghimire, M.S

4342438677 eta8xd@virginia.edu

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