Using empagliflozin to improve metabolic health in prediabetes
Use of Empagliflozin to Treat Prediabetes - a Randomized, Double-blind, Placebo-controlled 13-week Intervention Trial
This study is testing if the diabetes medication empagliflozin can help improve blood sugar control and overall health in overweight and obese adults with prediabetes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Oregon State University Academic / other |
| Locations | 1 site (Corvallis, Oregon) |
| Trial ID | NCT05426525 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of empagliflozin, a medication typically used for type 2 diabetes, on glucose metabolism in overweight and obese adults with prediabetes. It is a 13-week, double-blind, placebo-controlled trial comparing empagliflozin to a multivitamin placebo. Participants will undergo metabolic testing to assess changes in glucose regulation and skeletal muscle health throughout the intervention. The study aims to uncover the mechanisms by which empagliflozin may enhance glucose metabolism and overall metabolic health.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults with a BMI between 26-45 kg/m2 and stable weight, who are at risk for diabetes but do not have a diagnosis of type 2 diabetes.
Not a fit: Patients who are regularly engaged in moderate to vigorous exercise or those with major metabolic or cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for improving metabolic health and preventing the progression to type 2 diabetes in at-risk individuals.
How similar studies have performed: Other studies have shown promising results with similar medications in improving metabolic health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI 26-45 kg/m2 * Weight stable (± 10 lbs in previous 3 months) * Fasting blood glucose \<126 mg/dL or HbA1c \<6.5% (\<48mmol/mol) Exclusion Criteria: * Regular moderate-vigorous exercise (≥30 min/session on ≥2 days per week) * Pregnancy, planning to become pregnant or nursing * Lidocaine allergy * Current or recent smoking or nicotine use (≤ 1-year abstention) * Medications including glucose lowering medications and supplements (SGLT2 inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidase inhibitors; beta-blockers; diuretics * Major metabolic or cardiovascular conditions (e.g., type 1 diabetes, Crohn's disease, untreated hypo- or hyperthyroid, cancer, coronary artery disease, tachycardia, prior bariatric surgery, peripheral vascular disease, liver diseases (e.g., cirrhosis) * Diagnosed type 2 diabetes. In absence of diagnosis, two separate samples with test results of fasting blood glucose ≥126 mg/dL or HbA1c ≥6.5% (48 mmol/mol). * Contraindications/precautions for empagliflozin (impaired renal function (EGR\<60), history of: empagliflozin hypersensitivity, ketoacidosis, hypotension, recurring urinary tract or genital mycotic infections, amputation)
Where this trial is running
Corvallis, Oregon
- Oregon State University — Corvallis, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Sean A Newsom, Ph.D. — Oregon State University
- Study coordinator: Sean A Newsom, Ph.D.
- Email: sean.newsom@oregonstate.edu
- Phone: (541) 737-1613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.