Use of Empagliflozin to Treat Prediabetes
Part of paid clinical trials in Corvallis, Oregon.
- Sponsor
- Oregon State University
- Study ID
- NCT05426525
- Phase
- PHASE4
- Status
- Active Not Recruiting
Conditions
- Overweight and Obesity
- PreDiabetes
- Prediabetic State
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 59 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empagliflozin — DRUGParticipants will take 10mg empagliflozin per day for 2 weeks. Absent contraindications, dosing will be increased to 25 mg empagliflozin per day for the next 11 weeks.
- Multivitamin-Placebo — DRUGParticipants will take 1 multivitamin per day for 13 weeks.
Study Details
The overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).
Key Dates
- Start date
- Oct 13, 2022
- Status verified
- Jan 2026
- Primary completion
- May 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: EmpagliflozinParticipants will be provided 10-25mg empagliflozin per day for 13 weeks.
- Placebo Comparator: Multivitamin-PlaceboParticipants will be provided 1 multivitamin-placebo per day for 13 weeks.
Primary Outcome Measure
Insulin-stimulated glucose disposal [ Time Frame: Insulin-stimulated glucose disposal is measured before the start of the intervention (baseline) and during week 13 of the intervention. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Oregon State University | Corvallis | Oregon | 97331 | - |
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