Status:
COMPLETED
Use of Empagliflozin to Treat Prediabetes
Lead Sponsor:
Oregon State University
Collaborating Sponsors:
Samaritan Health Services
Conditions:
PreDiabetes
Prediabetic State
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05426525
Start Date
October 13 2022
End Date
August 30 2024
Last Update
June 12 2025
Active Locations (1)
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1
Oregon State University
Corvallis, Oregon, United States, 97331