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| ID | Type | Description | Link |
|---|---|---|---|
| VISN6CDA2024 | Other Identifier | Veterans Integrated Service Network 6 (Mid-Atlantic) Career Development Award |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | Participants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. |
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| Standard Care plus empagliflozin | Experimental | Participants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. They will also receive empagliflozin 10mg daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10mg daily | Drug | This intervention will assess recruitment and retention (feasibility trial). |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Number of participants screened during study period Number of participants randomized during study period Number of participants enrolled during study period | 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Renal function (ml/min) |
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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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles George VA Medical Center | Asheville | North Carolina | 28805 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2025 | Jul 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Lifestyle education | Other | This intervention is considered standard care for prediabetes. |
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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.
| 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. | 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. | Every visit (baseline (T), T+2-4 weeks, T+12 weeks) |
| Adverse Events | 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. | 12 weeks |
| D004700 | Endocrine System Diseases |