Prediabetes effects 96 million people 18 years of age or older. It is important to identify treatment options to slow or prevent progression to diabetes. It is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney complications, both common and costly complications of diabetes. This is a 12-week, open-label pilot feasibility study assessing the use of empagliflozin in prediabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
This intervention will assess recruitment and retention (feasibility trial).
This intervention is considered standard care for prediabetes.
Charles George VA Medical Center
Asheville, North Carolina, United States
Recruitment
Number of participants screened during study period Number of participants randomized during study period Number of participants enrolled during study period
Time frame: 12 weeks
Retention
Number of participants enrolled who complete the study Number of participants enrolled who do not complete the study and reason for not completing the study
Time frame: 12 weeks
HbA1c (%)
HbA1c measured at baseline (visit 1) and 12 weeks (visit 3) will be reported as aggregate data for change from baseline to visit 3 for control group and exposure group.
Time frame: 12 weeks
Renal function (ml/min)
estimated GFR (eGFR) (ml/min) will be collected at each study visit and reported as aggregate data for change from baseline to visit 2 and visit 3 for control group and exposure group.
Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Weight (kg)
Weight (kg) will be collected at each study visit and reported as aggregate data for change from baseline to visit 2 and visit 3 for control group and exposure group.
Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Blood pressure (mmHg)
Average of 2 sitting blood pressure measurements (mmHg) will be collected at each study visit and reported as aggregate data for change from baseline to visit 2 and visit 3 for control group and exposure group.
Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Adverse Events
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Total number of adverse events occurring among enrolled participants in each group as well as type of adverse event. At conclusion of study will report percent of adverse events reported with each group, i.e. number of participants in control group reporting adverse event/total number of participants enrolled in control group.
Time frame: 12 weeks