MedPath

Metformin and Vascular Function in Prediabetes

Phase 2
Not yet recruiting
Conditions
PreDiabetes
Registration Number
NCT06526494
Lead Sponsor
Diana Jalal
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not yet recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Inclusion Criteria:<br><br> - Age 18-55 years<br><br> - Prediabetes defined as an HbA1c between 5.7% and 6.4%<br><br> - Able to provide informed consent<br><br>Exclusion Criteria:<br><br> - Current use of metformin or metformin use within the past 12 months<br><br> - Current use of medicated contraindicated for use with metformin<br><br> - Current use of vitamin C supplement<br><br> - Current smoker or quit smoking within the last 6 months<br><br> - Pregnant, breastfeeding, planning to become pregnant, or unwilling to use adequate<br> birth control<br><br> - Uncontrolled hypertension (Systolic blood pressure >140 mmHg)<br><br> - Body Mass Index > 40 kg/m2<br><br> - History of diabetes, myocardial infarction, heart failure, liver disease, or chronic<br> kidney disease (estimated glomerular filtration rate < 45 ml/min/1.73m2)<br><br> - History of lactic acidosis<br><br> - History of alcohol abuse<br><br> - Severe infection within the last 30 days<br><br> - Immunosuppressive therapy within the past year<br><br> - Life expectancy < 1 year<br><br> - Allergy to metformin, nitroglycerin, sodium nitroprusside, ringer's lactate<br><br> - Study compliance: Unwilling to fast overnight, have an intravenous catheter placed,<br> take a study drug for 12 weeks, or visit Iowa campus 6 times within a 12-16 week<br> period

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Macrovascular endothelial function
Secondary Outcome Measures
NameTimeMethod
Microvascular endothelial function
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