Use of Empagliflozin to Treat Prediabetes

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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 with prediabetes, 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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon State University
• Collaborator: Samaritan Health Services
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• BMI 26-45 kg/m2

• Weight stable (± 2 kg in previous 6 months)

• Prediabetes:

• fasting blood glucose 100-125 mg/dL, or

• 2-hour plasma glucose 140-199 mg/dL after 75 g glucose load, or

• HbA1c 5.7-6.4% (39-47 mmol/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)

• Type 2 diabetes:

• fasting blood glucose ≥126 mg/dL, or

• 2-hour plasma glucose ≥200 mg/dL after 75 g glucose load, 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)