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Official title Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes
ClinicalTrials.gov ID: NCT07131384
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.