Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Virginia
About this trial
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
Qualifiers
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)
Disqualifiers
Estimated Glomerular filtration rate (GFR) ≤ 45
Body mass index ≥ 40 Kg/m2
HbA1c > 6.4%
Smokers within the last 5 years
Trial design
Treatments tested in this trial
- Dietary Supplement: Inorganic Nitrate (Beetroot juice)
- Dietary supplement: Placebo (Nitrate-depleted beetroot juice)
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov