Use of Empagliflozin to Treat Prediabetes

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: PreDiabetes, Prediabetic State, Overweight and Obesity

In brief

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 facts

Study ID

NCT05426525

Run by

Oregon State University

People needed

60

Starts

2022-10-13

Expected to finish

2026-12-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• Oregon State University — Corvallis, Oregon, United States

Full record on ClinicalTrials.gov

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