[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603043":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":64,"collaborators":32,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Comparator (Naive to metformin)","EXPERIMENTAL","Participants will supplement with nitrate-rich beetroot juice (BRJ) for 4 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 3 days, and 12.9 mmol 2 hours before the lab visit. Supplement order based on randomization and crossover will happen after a minimum of a 7-day washout period.",[13],"Dietary Supplement: Dietary Supplement: Inorganic Nitrate (Beetroot juice)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator (Naive to metformin)","PLACEBO_COMPARATOR","Participants will supplement with nitrate-depleted beetroot juice (BRJ) for 4 days: 6.45 mmol of NO3 in the morning and 6.45 mmol in the evening for 3 days, and 12.9 mmol 2 hours before the lab visit. Supplement order based on randomization and crossover will happen after a minimum of a 7-day washout period.",[19],"Dietary Supplement: Dietary supplement: Placebo (Nitrate-depleted beetroot juice)",{"label":21,"type":10,"description":11,"interventionNames":22},"Active Comparator (Taking metformin)",[13],{"label":24,"type":16,"description":17,"interventionNames":25},"Placebo Comparator (Taking metformin)",[19],[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Dietary Supplement: Inorganic Nitrate (Beetroot juice)","Participants will be supplemented with inorganic nitrate in the form of beetroot juice for 4 days (12.9 mmol of NO3\u002Fday), and their vascular health, insulin sensitivity, and exercise capacity will be measured post-supplementation. This is a randomized crossover design with 2 parallel groups (Group 1: Currently taking metformin, Group 2: Naive to metformin).",[9,21],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Dietary supplement: Placebo (Nitrate-depleted beetroot juice)","Participants will be supplemented with nitrate-depleted beetroot juice for 4 days (\\\u003C0.01 mmol NO3\u002Fday), and their vascular health, insulin sensitivity, and exercise capacity will be measured post-supplementation. This is a randomized crossover design with 2 parallel groups (Group 1: Currently taking metformin, Group 2: Naive to metformin).",[15,24],[38],{"name":39,"affiliation":5,"role":40},"Jason Allen, PhD","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":32,"email":46},"Money Ghimire, M.S","CONTACT","4342438677","eta8xd@uvahealth.org",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Charlottesville","Virginia","22903","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-78.47668,38.02931,{"lat":59,"lon":58},[62],{"name":32,"role":44,"phone":63,"phoneExt":32,"email":46},"434-243-8677",{"type":40,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Jason Allen","Professor","100603043","interaction-between-inorganic-nitrate-supplementation-and-metformin-in-individuals-with-prediabetes-100603043",false,"NCT07131384","Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes","The Interaction Between Inorganic Nitrate Supplementation and Metformin on Exercise Capacity, Vascular Function, and Insulin Sensitivity in Individuals With Pre-Diabetes","NO3-PreDM","Inclusion Criteria:\n\n* Individuals who can communicate meaningfully with the investigator and can provide written consent.\n* Confirmed prediabetic individuals (ages 18-60 years old) (2-hour glucose of 140-199 mg\u002FdL following OGTT test or HbA1c between 5.7-6.4% tested on two occasions within 6 months).\n* Taking metformin (stable dose for at least a week) or naïve to metformin\n* Sedentary (\\\u003C1 day\u002Fweek of structured exercise)\n* Be able to perform exercise on a cycle ergometer without assistance\n* Stable medication regimen for the last 6 months\n* If female, have a normal menstrual cycle\n\nExclusion Criteria:\n\n* Estimated Glomerular filtration rate (GFR) ≤ 45\n* Body mass index ≥ 40 Kg\u002Fm2\n* HbA1c \\> 6.4%\n* Smokers within the last 5 years\n* Has experienced significant weight loss \\~3 kg in the last three months or is taking any weight loss drugs\n* Current medical condition that prohibits exercising at high intensities\n* Currently on hormone replacement of any kind\n* History of myocardial infarction, cerebrovascular event, acute or unstable disease other than pre-diabetes or obesity\n* 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))\n* Oral antibiotic use within the previous four weeks, including over-the-counter antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use\n* Oral cancer\u002Fsevere oral disease\n* Uncontrolled hypertension (\\>140\u002F90)\n* Had hysterectomy or oophorectomy\n* Fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking participants","ALL","18 Years","60 Years",{"count":79,"type":80},24,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.",[86,87,88,89,90],"Males","Females","Sedentary","Metformin","Prediabetes",[92,93,94,95,96],"Prediabetic Individuals","Exercise Capacity","Vascular health","Inorganic nitrate","Insulin Sensitivity","2026-06-02",{"date":99,"type":100},"2026-06-03","ACTUAL",{"date":102,"type":100},"2026-01-01",{"date":104,"type":80},"2027-06-30",{"name":5,"class":6},1]