Prediabetes
Conditions
Brief summary
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.
Interventions
DRUGEmpagliflozin 10mg daily
This intervention will assess recruitment and retention (feasibility trial).
OTHERLifestyle education
This intervention is considered standard care for prediabetes.
Sponsors
Charles George VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of prediabetes defined by HbA1c \>5.7% and \<6.5% or fasting glucose 100-125 mg/dL with documentation of diagnosis (ICD-10 code) within electronic health record at time of enrollment * Age 35 to 60 years at time of enrollment * Able to read and speak English
Exclusion criteria
* Diagnosis of diabetes (type 2 or type 1) * Contraindication to SGLT2i medication per medication labeling, prior adverse reaction to SGLT2i medication, or received SGLT2i medication within the 6 months prior to enrollment * Currently prescribed an antihyperglycemic agent approved for treatment of type 2 diabetes or taking any FDA-approved weight loss agent or over-the-counter supplement promoted for weight loss * Veterans unable to complete informed consent process (Veterans with impaired decision-making ability or who require use of a legally authorized representative) * Women who are pregnant or may become pregnant * Veterans with neurogenic bladder, indwelling catheter, or urinary tract infection within the previous 12 months requiring hospitalization or emergency department visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 12 weeks | Number of participants screened during study period Number of participants randomized during study period Number of participants enrolled during study period |
| Retention | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight (kg) | Every visit (baseline (T), T+2-4 weeks, T+12 weeks) | 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. |
| HbA1c (%) | 12 weeks | 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. |
| Adverse Events | 12 weeks | 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. |
| Blood pressure (mmHg) | Every visit (baseline (T), T+2-4 weeks, T+12 weeks) | 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. |
| Renal function (ml/min) | Every visit (baseline (T), T+2-4 weeks, T+12 weeks) | 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. |
Countries
United States
Outcome results
None listed