Use of Empagliflozin to Treat Prediabetes
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).
Conditions:
🦠 PreDiabetes 🦠 Prediabetic State 🦠 Overweight and Obesity
🗓️ Study Start (Actual) 13 October 2022
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) April 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Corvallis, Oregon, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to 59 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 June 2022
  • First Submitted that Met QC Criteria 16 June 2022
  • First Posted 22 June 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 June 2023
  • Last Update Posted 28 June 2023
  • Last Verified June 2023