Use of Empagliflozin to Treat Prediabetes

Last updated: January 22, 2026
Sponsor: Oregon State University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Diabetes (Pediatric)

Hypertriglyceridemia

Diabetes Prevention

Treatment

Empagliflozin

Multivitamin-Placebo

Clinical Study ID

NCT05426525
OregonSU
  • Ages 18-59
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

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 (SGLT2inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidaseinhibitors; beta-blockers; diuretics

  • Major metabolic or cardiovascular conditions (e.g., type 1 diabetes, Crohn'sdisease, 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 testresults 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, recurringurinary tract or genital mycotic infections, amputation)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Empagliflozin
Phase: 4
Study Start date:
October 13, 2022
Estimated Completion Date:
December 31, 2026

Study Description

The overall study design is a 13-week, double-blind, placebo-controlled intervention trial, testing the ability of empagliflozin to improve glucose metabolism among overweight and obese individuals at risk for diabetes (compared with a multivitamin-placebo). The study involves metabolic testing before and during the intervention to identify changes in outcomes as a function of the intervention and to ensure participant safety. The study involves 9 visits to the Samaritan Athletic Medicine Center on the campus of Oregon State University in Corvallis, Oregon. Full completion of the study is anticipated to take ~4 months. The project is being completed in collaboration with physicians at Samaritan Health Services.

Connect with a study center

  • Oregon State University

    Corvallis, Oregon 97331
    United States

    Active - Recruiting

  • Oregon State University

    Corvallis 5720727, Oregon 5744337 97331
    United States

    Site Not Available

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